22 System Validation jobs in India
Senior System Validation Engineer

Posted 4 days ago
Job Viewed
Job Description
System Validation Lead are said to have a ""break-the-part"" mentality. This means they spend some of their time working to identify the use-cases in which the device will stop working as intended and understand the impact and cause of those failures. Sometimes, those are acceptable failures, but others we may need to mitigate for quality, safety, or other reasons. Plus, we want to ensure that our parts are consistently performing to the specifications that we set in our data sheet, and even to some more conservative limits or as defined in the VVCM (validation/verification compliance matrix). To do this, they must design PCB boards and develop automation software that will increase coverage and reduce data collection time. Validation engineers will also design, develop, and implement necessary methods of measuring device performance and troubleshooting any related systems, equipment or device issues that arise. Validation engineers are often working in a post-silicon lab or on the software programs required to run their measurements.
**Why IPP-MPP**
IPP-MPP product line offers high performance, innovative and cost-effective power solutions for a broad range of customer applications in enterprise, communications and automotive which include multiple phase DC/DC controllers, smart power stages, and sequencers. In MPP, our mission is to deliver the converter solutions which power large CPU, SOC, ASIC platforms in the rapidly expanding Enterprise Computing/Datacenter market. Target platforms include Intel, AMD, ARM, NVidia and custom ASIC/FPGAs from various vendors.
**Why TI?**
+ Engineer your future. We empower our employees to truly own their career and development. Come collaborate with some of the smartest people in the world to shape the future of electronics.
+ We're different by design. Diverse backgrounds and perspectives are what push innovation forward and what make TI stronger. We value each and every voice, and look forward to hearing yours. Meet the people of TI ( Benefits that benefit you. We offer competitive pay and benefits designed to help you and your family live your best life. Your well-being is important to us.
**About Texas Instruments**
Texas Instruments Incorporated (Nasdaq: TXN) is a global semiconductor company that designs, manufactures and sells analog and embedded processing chips for markets such as industrial, automotive, personal electronics, communications equipment and enterprise systems. At our core, we have a passion to create a better world by making electronics more affordable through semiconductors. This passion is alive today as each generation of innovation builds upon the last to make our technology more reliable, more affordable and lower power, making it possible for semiconductors to go into electronics everywhere. Learn more at TI.com .
Texas Instruments is an equal opportunity employer and supports a diverse, inclusive work environment.
If you are interested in this position, please apply to this requisition.
**Minimum requirements:**
+ Minimum education (ie bachelor's degree in electrical engineering)
+ 7+ years of experience.
**Preferred qualifications:**
+ Ability to establish strong relationships with key stakeholders critical to success, both internally and externally
+ Strong verbal and written communication skills
+ Ability to quickly ramp on new systems and processes
+ Demonstrated strong interpersonal, analytical and problem-solving skills
+ Ability to work in teams and collaborate effectively with people in different functions
+ Ability to take the initiative and drive for results
+ Strong time management skills that enable on-time project delivery
**ECL/GTC Required:** Yes
Computer System Validation Engineer
Posted today
Job Viewed
Job Description
About Apexon
Apexon is a digital-first technology services firm that accelerates business transformation and delivers human-centric digital experiences. We partner with clients across their digital journey, helping them outperform their competition through speed and innovation.
Our core competencies span across AI, analytics, app development, cloud, commerce, CX, data, DevOps, IoT, mobile, quality engineering, and UX. With deep domain expertise in BFSI, healthcare, and life sciences, we help organizations unlock the full potential of digital. Backed by Goldman Sachs Asset Management and Everstone Capital, Apexon operates across 15 global offices and 10 delivery centers on four continents.
We enable #HumanFirstDIGITAL.
Job Title: Manual + Computer System Validation Lead
Location: Bangalore (Hybrid)
Joining Timeline: Immediate to 30 Days
Experience Required: 8+ Years (including 2–3 years in a lead role)
Job Summary: We are looking for a Validation Lead with strong experience in manual testing, validation strategy, and documentation. This role involves leading validation efforts while also contributing individually to project delivery. The ideal candidate will bring deep quality assurance expertise, especially within regulated environments, and have a proactive, hands-on approach to leading teams and driving excellence.
Key Responsibilities
- Lead and manage validation/testing efforts for critical programs in an Agile environment.
- Develop and review key test documentation: Test Plans, RTMs, Test Strategies, Test Data, Bug Reports, and Test Execution Reports.
- Design, execute, and maintain test cases; track and resolve defects efficiently.
- Guide and mentor team members in validation best practices and documentation standards.
- Collaborate with cross-functional teams to ensure quality deliverables.
- Leverage test management tools like JIRA and ALM for documentation and defect lifecycle tracking.
- Perform various manual testing techniques including Functional, Regression, and System Testing.
- Conduct database testing and validate backend integrity using SQL.
- Ensure compliance with applicable validation standards and regulatory guidelines.
Required Skills & Qualifications
- Minimum 8+ years of QA/Validation experience, with 2–3 years in a lead capacity.
- Familiarity with 21 CFR Part 11 or similar regulatory frameworks.
- Deep expertise in manual testing, test design, and documentation.
- Strong understanding of defect management, prioritization (Severity vs. Priority), and triage processes.
- Proficient in JIRA and ALM for test and defect tracking.
- Hands-on experience with Agile/Scrum methodologies.
- Working knowledge of Database Testing and SQL.
- Domain experience in Life Sciences, Healthcare, or Clinical Trials.
Additional Attributes
- Proven ability to balance leadership responsibilities with individual contributions.
- Excellent communication, documentation, and stakeholder management skills.
- Self-motivated, detail-oriented, and accountable.
Our Commitment to Diversity & Inclusion
Apexon is proud to be Certified™ by Great Place to Work® across the USA (five-time winner as of 2025), India (seven consecutive certifications as of 2024), and the UK.
We are an equal opportunity employer and are committed to building an inclusive environment for all employees. We prohibit discrimination and harassment of any kind and ensure fair treatment regardless of gender, race, ethnicity, religion, disability, sexual orientation, gender identity or expression, or any other status protected by law.
Learn more: Job Applicant Privacy Policy
Perks & Benefits
Our rewards and benefits are crafted to promote personal and professional growth while caring for your well-being and that of your loved ones:
- Group Health Insurance for a family of four
- Term Life & Accident Insurance
- Paid Holidays & Earned Leaves
- Paid Parental Leave
- Learning & Career Development Programs
- Comprehensive Employee Wellness Initiatives
Computer System Validation Engineer
Posted today
Job Viewed
Job Description
Apexon is a digital-first technology services firm that accelerates business transformation and delivers human-centric digital experiences. We partner with clients across their digital journey, helping them outperform their competition through speed and innovation.
Our core competencies span across AI, analytics, app development, cloud, commerce, CX, data, DevOps, IoT, mobile, quality engineering, and UX. With deep domain expertise in BFSI, healthcare, and life sciences, we help organizations unlock the full potential of digital. Backed by Goldman Sachs Asset Management and Everstone Capital, Apexon operates across 15 global offices and 10 delivery centers on four continents.
We enable #HumanFirstDIGITAL.
Job Title: Manual + Computer System Validation Lead
Location: Bangalore (Hybrid)
Joining Timeline: Immediate to 30 Days
Experience Required: 8+ Years (including 2–3 years in a lead role)
Job Summary: We are looking for a Validation Lead with strong experience in manual testing, validation strategy, and documentation. This role involves leading validation efforts while also contributing individually to project delivery. The ideal candidate will bring deep quality assurance expertise, especially within regulated environments, and have a proactive, hands-on approach to leading teams and driving excellence.
Key Responsibilities
- Lead and manage validation/testing efforts for critical programs in an Agile environment.
- Develop and review key test documentation: Test Plans, RTMs, Test Strategies, Test Data, Bug Reports, and Test Execution Reports.
- Design, execute, and maintain test cases; track and resolve defects efficiently.
- Guide and mentor team members in validation best practices and documentation standards.
- Collaborate with cross-functional teams to ensure quality deliverables.
- Leverage test management tools like JIRA and ALM for documentation and defect lifecycle tracking.
- Perform various manual testing techniques including Functional, Regression, and System Testing.
- Conduct database testing and validate backend integrity using SQL.
- Ensure compliance with applicable validation standards and regulatory guidelines.
Required Skills & Qualifications
- Minimum 8+ years of QA/Validation experience, with 2–3 years in a lead capacity.
- Familiarity with 21 CFR Part 11 or similar regulatory frameworks.
- Deep expertise in manual testing, test design, and documentation.
- Strong understanding of defect management, prioritization (Severity vs. Priority), and triage processes.
- Proficient in JIRA and ALM for test and defect tracking.
- Hands-on experience with Agile/Scrum methodologies.
- Working knowledge of Database Testing and SQL.
- Domain experience in Life Sciences, Healthcare, or Clinical Trials.
Additional Attributes
- Proven ability to balance leadership responsibilities with individual contributions.
- Excellent communication, documentation, and stakeholder management skills.
- Self-motivated, detail-oriented, and accountable.
Our Commitment to Diversity & Inclusion
Apexon is proud to be Certified™ by Great Place to Work® across the USA (five-time winner as of 2025), India (seven consecutive certifications as of 2024), and the UK.
We are an equal opportunity employer and are committed to building an inclusive environment for all employees. We prohibit discrimination and harassment of any kind and ensure fair treatment regardless of gender, race, ethnicity, religion, disability, sexual orientation, gender identity or expression, or any other status protected by law.
Learn more: Job Applicant Privacy Policy
Perks & Benefits
Our rewards and benefits are crafted to promote personal and professional growth while caring for your well-being and that of your loved ones:
- Group Health Insurance for a family of four
- Term Life & Accident Insurance
- Paid Holidays & Earned Leaves
- Paid Parental Leave
- Learning & Career Development Programs
- Comprehensive Employee Wellness Initiatives
Computer System Validation Engineer
Posted today
Job Viewed
Job Description
About Apexon
Apexon is a digital-first technology services firm that accelerates business transformation and delivers human-centric digital experiences. We partner with clients across their digital journey, helping them outperform their competition through speed and innovation.
Our core competencies span across AI, analytics, app development, cloud, commerce, CX, data, DevOps, IoT, mobile, quality engineering, and UX. With deep domain expertise in BFSI, healthcare, and life sciences, we help organizations unlock the full potential of digital. Backed by Goldman Sachs Asset Management and Everstone Capital, Apexon operates across 15 global offices and 10 delivery centers on four continents.
We enable #HumanFirstDIGITAL.
Job Title: Manual + Computer System Validation Lead
Location: Bangalore (Hybrid)
Joining Timeline: Immediate to 30 Days
Experience Required: 8+ Years (including 2–3 years in a lead role)
Job Summary: We are looking for a Validation Lead with strong experience in manual testing, validation strategy, and documentation. This role involves leading validation efforts while also contributing individually to project delivery. The ideal candidate will bring deep quality assurance expertise, especially within regulated environments, and have a proactive, hands-on approach to leading teams and driving excellence.
Key Responsibilities
- Lead and manage validation/testing efforts for critical programs in an Agile environment.
- Develop and review key test documentation: Test Plans, RTMs, Test Strategies, Test Data, Bug Reports, and Test Execution Reports.
- Design, execute, and maintain test cases; track and resolve defects efficiently.
- Guide and mentor team members in validation best practices and documentation standards.
- Collaborate with cross-functional teams to ensure quality deliverables.
- Leverage test management tools like JIRA and ALM for documentation and defect lifecycle tracking.
- Perform various manual testing techniques including Functional, Regression, and System Testing.
- Conduct database testing and validate backend integrity using SQL.
- Ensure compliance with applicable validation standards and regulatory guidelines.
Required Skills & Qualifications
- Minimum 8+ years of QA/Validation experience, with 2–3 years in a lead capacity.
- Familiarity with 21 CFR Part 11 or similar regulatory frameworks.
- Deep expertise in manual testing, test design, and documentation.
- Strong understanding of defect management, prioritization (Severity vs. Priority), and triage processes.
- Proficient in JIRA and ALM for test and defect tracking.
- Hands-on experience with Agile/Scrum methodologies.
- Working knowledge of Database Testing and SQL.
- Domain experience in Life Sciences, Healthcare, or Clinical Trials.
Additional Attributes
- Proven ability to balance leadership responsibilities with individual contributions.
- Excellent communication, documentation, and stakeholder management skills.
- Self-motivated, detail-oriented, and accountable.
Our Commitment to Diversity & Inclusion
Apexon is proud to be Certified™ by Great Place to Work® across the USA (five-time winner as of 2025), India (seven consecutive certifications as of 2024), and the UK.
We are an equal opportunity employer and are committed to building an inclusive environment for all employees. We prohibit discrimination and harassment of any kind and ensure fair treatment regardless of gender, race, ethnicity, religion, disability, sexual orientation, gender identity or expression, or any other status protected by law.
Learn more: Job Applicant Privacy Policy
Perks & Benefits
Our rewards and benefits are crafted to promote personal and professional growth while caring for your well-being and that of your loved ones:
- Group Health Insurance for a family of four
- Term Life & Accident Insurance
- Paid Holidays & Earned Leaves
- Paid Parental Leave
- Learning & Career Development Programs
- Comprehensive Employee Wellness Initiatives
Computer System Validation Engineer
Posted 9 days ago
Job Viewed
Job Description
About Apexon
Apexon is a digital-first technology services firm that accelerates business transformation and delivers human-centric digital experiences. We partner with clients across their digital journey, helping them outperform their competition through speed and innovation.
Our core competencies span across AI, analytics, app development, cloud, commerce, CX, data, DevOps, IoT, mobile, quality engineering, and UX. With deep domain expertise in BFSI, healthcare, and life sciences, we help organizations unlock the full potential of digital. Backed by Goldman Sachs Asset Management and Everstone Capital, Apexon operates across 15 global offices and 10 delivery centers on four continents.
We enable #HumanFirstDIGITAL.
Job Title: Manual + Computer System Validation Lead
Location: Bangalore (Hybrid)
Joining Timeline: Immediate to 30 Days
Experience Required: 8+ Years (including 2–3 years in a lead role)
Job Summary: We are looking for a Validation Lead with strong experience in manual testing, validation strategy, and documentation. This role involves leading validation efforts while also contributing individually to project delivery. The ideal candidate will bring deep quality assurance expertise, especially within regulated environments, and have a proactive, hands-on approach to leading teams and driving excellence.
Key Responsibilities
- Lead and manage validation/testing efforts for critical programs in an Agile environment.
- Develop and review key test documentation: Test Plans, RTMs, Test Strategies, Test Data, Bug Reports, and Test Execution Reports.
- Design, execute, and maintain test cases; track and resolve defects efficiently.
- Guide and mentor team members in validation best practices and documentation standards.
- Collaborate with cross-functional teams to ensure quality deliverables.
- Leverage test management tools like JIRA and ALM for documentation and defect lifecycle tracking.
- Perform various manual testing techniques including Functional, Regression, and System Testing.
- Conduct database testing and validate backend integrity using SQL.
- Ensure compliance with applicable validation standards and regulatory guidelines.
Required Skills & Qualifications
- Minimum 8+ years of QA/Validation experience, with 2–3 years in a lead capacity.
- Familiarity with 21 CFR Part 11 or similar regulatory frameworks.
- Deep expertise in manual testing, test design, and documentation.
- Strong understanding of defect management, prioritization (Severity vs. Priority), and triage processes.
- Proficient in JIRA and ALM for test and defect tracking.
- Hands-on experience with Agile/Scrum methodologies.
- Working knowledge of Database Testing and SQL.
- Domain experience in Life Sciences, Healthcare, or Clinical Trials.
Additional Attributes
- Proven ability to balance leadership responsibilities with individual contributions.
- Excellent communication, documentation, and stakeholder management skills.
- Self-motivated, detail-oriented, and accountable.
Our Commitment to Diversity & Inclusion
Apexon is proud to be Certified™ by Great Place to Work® across the USA (five-time winner as of 2025), India (seven consecutive certifications as of 2024), and the UK.
We are an equal opportunity employer and are committed to building an inclusive environment for all employees. We prohibit discrimination and harassment of any kind and ensure fair treatment regardless of gender, race, ethnicity, religion, disability, sexual orientation, gender identity or expression, or any other status protected by law.
Learn more: Job Applicant Privacy Policy
Perks & Benefits
Our rewards and benefits are crafted to promote personal and professional growth while caring for your well-being and that of your loved ones:
- Group Health Insurance for a family of four
- Term Life & Accident Insurance
- Paid Holidays & Earned Leaves
- Paid Parental Leave
- Learning & Career Development Programs
- Comprehensive Employee Wellness Initiatives
Computer System Validation Engineer
Posted today
Job Viewed
Job Description
About Apexon
Apexon is a digital-first technology services firm that accelerates business transformation and delivers human-centric digital experiences. We partner with clients across their digital journey, helping them outperform their competition through speed and innovation.
Our core competencies span across AI, analytics, app development, cloud, commerce, CX, data, DevOps, IoT, mobile, quality engineering, and UX. With deep domain expertise in BFSI, healthcare, and life sciences, we help organizations unlock the full potential of digital. Backed by Goldman Sachs Asset Management and Everstone Capital, Apexon operates across 15 global offices and 10 delivery centers on four continents.
We enable #HumanFirstDIGITAL.
Job Title: Manual + Computer System Validation Lead
Location: Bangalore (Hybrid)
Joining Timeline: Immediate to 30 Days
Experience Required: 8+ Years (including 2–3 years in a lead role)
Job Summary: We are looking for a Validation Lead with strong experience in manual testing, validation strategy, and documentation. This role involves leading validation efforts while also contributing individually to project delivery. The ideal candidate will bring deep quality assurance expertise, especially within regulated environments, and have a proactive, hands-on approach to leading teams and driving excellence.
Key Responsibilities
- Lead and manage validation/testing efforts for critical programs in an Agile environment.
- Develop and review key test documentation: Test Plans, RTMs, Test Strategies, Test Data, Bug Reports, and Test Execution Reports.
- Design, execute, and maintain test cases; track and resolve defects efficiently.
- Guide and mentor team members in validation best practices and documentation standards.
- Collaborate with cross-functional teams to ensure quality deliverables.
- Leverage test management tools like JIRA and ALM for documentation and defect lifecycle tracking.
- Perform various manual testing techniques including Functional, Regression, and System Testing.
- Conduct database testing and validate backend integrity using SQL.
- Ensure compliance with applicable validation standards and regulatory guidelines.
Required Skills & Qualifications
- Minimum 8+ years of QA/Validation experience, with 2–3 years in a lead capacity.
- Familiarity with 21 CFR Part 11 or similar regulatory frameworks.
- Deep expertise in manual testing, test design, and documentation.
- Strong understanding of defect management, prioritization (Severity vs. Priority), and triage processes.
- Proficient in JIRA and ALM for test and defect tracking.
- Hands-on experience with Agile/Scrum methodologies.
- Working knowledge of Database Testing and SQL.
- Domain experience in Life Sciences, Healthcare, or Clinical Trials.
Additional Attributes
- Proven ability to balance leadership responsibilities with individual contributions.
- Excellent communication, documentation, and stakeholder management skills.
- Self-motivated, detail-oriented, and accountable.
Our Commitment to Diversity & Inclusion
Apexon is proud to be Certified™ by Great Place to Work® across the USA (five-time winner as of 2025), India (seven consecutive certifications as of 2024), and the UK.
We are an equal opportunity employer and are committed to building an inclusive environment for all employees. We prohibit discrimination and harassment of any kind and ensure fair treatment regardless of gender, race, ethnicity, religion, disability, sexual orientation, gender identity or expression, or any other status protected by law.
Learn more: Job Applicant Privacy Policy
Perks & Benefits
Our rewards and benefits are crafted to promote personal and professional growth while caring for your well-being and that of your loved ones:
- Group Health Insurance for a family of four
- Term Life & Accident Insurance
- Paid Holidays & Earned Leaves
- Paid Parental Leave
- Learning & Career Development Programs
- Comprehensive Employee Wellness Initiatives
Director, Computer System Validation/Assurance
Posted 1 day ago
Job Viewed
Job Description
Second Shift (Afternoons)
**Environmental Conditions**
Office
**Job Description**
Location:
India
Department:
IT CoE
Reports To:
IT CoE Sr. Director
Thermo Fisher Scientific is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are speeding up life sciences research, solving sophisticated analytical issues, improving efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to assist them!
Thermo Fisher's 4i Values of Integrity, Intensity, Innovation, and Involvement make up our culture and guide our employees' interactions - with our customers, suppliers, and partners, and with each other. These four values are the very foundation of our culture and are fundamental to our continued growth. We are an equal opportunity employer.
Our distributed team offers an unmatched mix of brand new technologies, purchasing convenience, and pharmaceutical services across our top-tier brands like Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
Thermo Fisher Scientific India is certified by GPTW for building a High-Trust, High-Performance Culture that strengthens our position as one of the world's most admired companies and takes us a step closer to achieving our 2030 Vision. Amidst the evolving economic environment, this certification for the consecutive 6th year is truly a reflection of our commitment to providing equal opportunity, embracing diversity, and fostering a culture that empowers our colleagues to make meaningful contributions and build exciting careers!
**Position Summary:**
The Director of Computer System Validation/Assurance (CSV/CSA) is responsible for the comprehensive leadership, strategy, execution, and governance of all validation activities related to computerized systems supporting GxP-regulated operations across the pharmaceutical CDMO environment. This role integrates regulatory compliance (21 CFR Part 11, EU Annex 11), GAMP 5 guidelines, ITIL service management practices, and DevOps-based automation frameworks to ensure systems are validated, auditable,
secure, and continuously improving as part of continual improvement to build a strong framework. This role will supervise a team across different global locations, working closely with IT, QA, regulatory, and operations groups, and acting as a key SME for internal customers and external auditors.
**Key Responsibilities:**
**Strategic Validation Leadership**
· Design, Develop and implement an inclusive CSV/CSA governance framework throughout the organization, integrating strategy, roadmap, performance indicators, and policies.
· Develop a harmonized global approach to validation that addresses system lifecycle, data integrity, cybersecurity, and scalability.
· Ensure full integration of CSA (Computer Software Assurance) methodology to focus validation on high-risk areas and reduce unnecessary testing.
· Collaborate with global digital transformation teams to embed validation requirements into digital and cloud-first initiatives.
**Validation Lifecycle & Compliance Oversight**
· Lead the complete lifecycle of GxP system validation: risk assessment, URS, FRS, configuration specs, traceability matrix, IQ/OQ/PQ protocols, and periodic review.
· Lead all aspects of qualification and revalidation efforts for ERP (e.g., SAP), LIMS, ELN, CDS, QMS, MES, and cloud-hosted GxP platforms.
· Maintain a central repository of validated systems with metadata including validation status, ownership, audit history, and system risk level.
· Implement robust change control processes aligned with validation maintenance and ensure audit trail and deviation management integrity.
**ITIL-Based IT Governance & Service Management**
· Integrate ITIL standard methodologies within the CSV process, encompassing incident, change, asset, configuration, and release management.
· Establish SLAs and OLAs between quality, IT, and system owners to define expectations for validated system support.
· Ensure accurate CMDB (Configuration Management Database) entries for all validated systems and components.
· Coordinate validation activities within ITSM platforms like ServiceNow, including automated change workflow approvals and e-signatures.
**DevOps, Agile, and Automation Enablement**
· Embed validation controls in CI/CD pipelines through risk-based gating, automated test verification, and release readiness assessments.
· Drive adoption of Infrastructure as Code (IaC), automated regression testing, and cloud- native validation patterns.
· Define and implement reusable validation templates, scripted testing libraries, and version-controlled documentation (e.g., Git).
· Collaborate with DevOps engineers, IT security, and platform architects to enforce compliance guardrails without stalling innovation.
**Audit, Inspection, and Data Integrity Readiness**
· Serve as the company's SME for all GxP computerized systems during regulatory agency
inspections and third-party audits.
· Ensure evidence is available for access management, audit trail reviews, electronic records/signatures, and configuration integrity.
· Perform internal audits to evaluate system readiness, alignment with SOPs, and proactive identification of data integrity risks.
· Lead remediation programs in response to audit observations including documentation updates, CAPA management, and training.
**Collaborative Engagement & Training**
· Develop a global training curriculum for IT, QA, laboratory, and operations staff on validation, CSA, and data integrity.
· Head communities of practice (CoPs) for CSV/CSA and system owners to foster alignment, learning, and sharing of standard processes.
· Collaborate closely with vendors during implementation, qualification, and SaaS onboarding to build appropriate validation packages and contracts (e.g., SLAs, Data Processing Agreements).
Team Leadership & Organizational Development
· Lead and mentor a hard-working team of CSV engineers, business analysts, IT validation specialists, and project leads.
· Set clear team objectives, career paths, and technical training plans aligned to both business and compliance priorities.
· Create global and site-level capacity plans to support growth in validation demand and system deployment initiatives.
**Continuous Improvement & Metrics**
· Define and front end aspects of critical metrics like cycle time for validation, trends in audit findings, usage of automation, and rate of defect leakage.
· Establish and build CSA adoption achievements across product and system categories.
· Regularly review system inventory, validation status, periodic review schedules, and CAPA closure efficiency to drive progress.
**Qualifications:**
**Education & Experience**
· Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering, or related technical field.
· 12-15+ years of experience in CSV, with at least 5 years in a global leadership role and global work culture
· Extensive experience with GxP-regulated systems, including SaaS, hybrid cloud, and on- premise applications in the CDMO or biopharma sector.
**Skills & Knowledge**
· Expert in GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA guidance.
· Sophisticated understanding of ITIL, Agile methodologies, DevOps, CI/CD, IaC, and cloud- native architectures.
· Showed strength in written and verbal communication, ability to influence and partner optimally.
· Proficient in tools such as ServiceNow, Jira, Git, Confluence, Azure DevOps, and electronic validation platforms.
**Preferred Qualifications:**
· PMP, ITIL v4, GAMP Practitioner, or CSA credential preferred.
· Experience in regulated product launches supported by validated systems.
· Familiarity with AI/ML model validation or GxP automation analytics frameworks.
· Background in global quality systems integration, cloud qualification, and third-party SaaS risk management would be an advantage
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Senior Computer System Validation Specialist

Posted 4 days ago
Job Viewed
Job Description
**Job Description**
**The Future Begins Here**
At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet.
Bengaluru, the city, which is India's epicenter of Innovation, has been selected to be home to Takeda's recently launched Innovation Capability Center. We invite you to join our digital transformation journey. In this role, you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement.
**At Takeda's ICC we Unite in Diversity**
Takeda is committed to creating an inclusive and collaborative workplace, where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda, and we welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our diverse team.
**About the role:**
The Senior Computer System Validation Specialist is responsible for managing the global information security risk program across the organization. This individual collaborates with business leaders to understand security and risk issues, oversees risk management and assessment efforts, and develops effective remediation programs. This role supports Takeda's mission by ensuring the security and compliance of IT systems and processes.
**Key Responsibilities**
+ Oversee the development and review of comprehensive validation documentation, including Validation Plans, URS, FS, IQ/OQ/PQ protocols, validation reports, and traceability matrices.
+ Conduct risk assessments for computer systems, identify potential vulnerabilities, and implement risk mitigation strategies.
+ Establish and maintain a robust change control process to manage system changes and updates in compliance with validation requirements.
+ Provide guidance on validation testing methodologies, including test design, execution, and documentation. Ensure that testing meets regulatory expectations.
+ Work with other departments to ensure alignment for an agreed upon state of control for computer systems.
+ Practice and stay current with ISPE GAMP best practices, FDA and EU GxP regulations, and applicable ISO standards.
+ Manage a team of professionals to drive validation activities for computer systems.
+ Work with other departments to ensure alignment for an agreed upon state of control for computer systems.
+ Provide training and guidance to team members on validation processes and procedures.
**Qualifications**
+ Min 5 years of experience in a similar role
+ Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences).
+ Proven experience in infrastructure qualification and computer system validation.
+ In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11).
+ Familiarity with cloud qualification practices (nice to have).
+ Strong analytical and problem-solving skills.
+ Excellent communication and teamwork abilities.
+ Attention to detail and a commitment to quality.
**WHAT TAKEDA CAN OFFER YOU:**
+ Takeda is certified as a Top Employer, not only in India, but also globally. No investment we make pays greater dividends than taking good care of our people.
+ At Takeda, you take the lead on building and shaping your own career.
+ Joining the ICC in Bengaluru will give you access to high-end technology, continuous training and a diverse and inclusive network of colleagues who will support your career growth.
**Benefits:**
It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:
+ Competitive Salary + Performance Annual Bonus
+ Flexible work environment, including hybrid working
+ Comprehensive Healthcare Insurance Plans for self, spouse, and children
+ Group Term Life Insurance and Group Accident Insurance programs
+ Employee Assistance Program
+ Broad Variety of learning platforms
+ Diversity, Equity, and Inclusion Programs
+ Reimbursements - Home Internet & Mobile Phone
+ Employee Referral Program
+ Leaves - Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 calendar days)
**About ICC in Takeda**
+ Takeda is leading a digital revolution. We're not just transforming our company; we're improving the lives of millions of patients who rely on our medicines every day.
+ As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.
#Li-Hybrid
**Locations**
IND - Bengaluru
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
Senior Computer System Validation Specialist
Posted today
Job Viewed
Job Description
Description
The Future Begins HereAt Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet.
Bengaluru, the city, which is India’s epicenter of Innovation, has been selected to be home to Takeda’s recently launched Innovation Capability Center. We invite you to join our digital transformation journey. In this role, you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement.
At Takeda’s ICC we Unite in Diversity
Takeda is committed to creating an inclusive and collaborative workplace, where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda, and we welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our diverse team.
About the role:
The Senior Computer System Validation Specialist is responsible for managing the global information security risk program across the organization. This individual collaborates with business leaders to understand security and risk issues, oversees risk management and assessment efforts, and develops effective remediation programs. This role supports Takeda's mission by ensuring the security and compliance of IT systems and processes.
Key Responsibilities
Oversee the development and review of comprehensive validation documentation, including Validation Plans, URS, FS, IQ/OQ/PQ protocols, validation reports, and traceability matrices.
Conduct risk assessments for computer systems, identify potential vulnerabilities, and implement risk mitigation strategies.
Establish and maintain a robust change control process to manage system changes and updates in compliance with validation requirements.
Provide guidance on validation testing methodologies, including test design, execution, and documentation. Ensure that testing meets regulatory expectations.
Work with other departments to ensure alignment for an agreed upon state of control for computer systems.
Practice and stay current with ISPE GAMP best practices, FDA and EU GxP regulations, and applicable ISO standards.
Manage a team of professionals to drive validation activities for computer systems.
Work with other departments to ensure alignment for an agreed upon state of control for computer systems.
Provide training and guidance to team members on validation processes and procedures.
Qualifications
Min 5 years of experience in a similar role
Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences).
Proven experience in infrastructure qualification and computer system validation.
In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11).
Familiarity with cloud qualification practices (nice to have).
Strong analytical and problem-solving skills.
Excellent communication and teamwork abilities.
Attention to detail and a commitment to quality.
WHAT TAKEDA CAN OFFER YOU:
Takeda is certified as a Top Employer, not only in India, but also globally. No investment we make pays greater dividends than taking good care of our people.
At Takeda, you take the lead on building and shaping your own career.
Joining the ICC in Bengaluru will give you access to high-end technology, continuous training and a diverse and inclusive network of colleagues who will support your career growth.
Benefits:
It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:
Competitive Salary + Performance Annual Bonus
Flexible work environment, including hybrid working
Comprehensive Healthcare Insurance Plans for self, spouse, and children
Group Term Life Insurance and Group Accident Insurance programs
Employee Assistance Program
Broad Variety of learning platforms
Diversity, Equity, and Inclusion Programs
Reimbursements – Home Internet & Mobile Phone
Employee Referral Program
Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 calendar days)
About ICC in Takeda
Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day.
As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.
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Locations
IND - BengaluruWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeSr Engineer I System Validation
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Job Description
At Visteon, the work we do is both relevant and recognized—not just by our organization, but by our peers, by industry-leading brands, and by millions of drivers around the world. That’s YOUR work.
And, as a truly global technology leader in the mobility space, focused on building cross-functional AND cross-cultural teams, we connect you with people who help you grow.
So here, whatever we do is not a job. It’s a mission. As a multi-billion-dollar leader of disruptive change in the industry, we are shaping the future, while enabling a cleaner environment. No other industry offers more fast-paced change and opportunity. We are in the midst of a mobility revolution that will completely change the way we interact with our vehicles, reduce the number of car accidents and fatalities, and make the world a cleaner place.
Visteon is at the epicenter of this mobility revolution.
Two major trends in the automotive industry – the shift to electric vehicles and vehicles with autonomous safety technologies – have created unique opportunities for Visteon. We are the only automotive provider focused exclusively on cockpit electronics – the fastest-growing segment in the industry.
And our team is ready for YOU. To show the world what you can do.
Validation JD
Understanding Customer Requirements (SPSS) / SRD documents and perform Functional Testing of Driver Information / Infotainment ECUs.
Involve in Test Script Update and keen to work towards Automation.
Involve in Test procedure development for new feature requirements.
Perform Functional Black Box Testing of Infotainment & Telematics Features.
Knowledge sharing to team on features worked.
Need to participate in Defect Triage meeting and demonstrate the issues identified to Requirements & Development Teams.
Use of tools for Testing, Defects Management, Configuration Management.
Typical Duties
Ability to work as a very good team member and share resources, work content to meet common team goals.
Work and collaborate internally within the team to deliver the Test scripts, procedures / Test Execution reports as planned.
Perform testing of products in an iterative, agile software lifecycle
Need to identify typical Use Case Scenarios happening in vehicle
Recreate issues reported by customer and ability to debug CAN logs.
Desired Competencies/Experience
Good Functional Black Box Testing Knowledge on Infotainment / Telematics features involving
Proficient in black box testing concepts such as equivalence class, boundary conditions, all pairs, all path, positive & negative tests, etc.
Knowledge on Scripting is Mandatory (Winwrap or CAPL or Python or Robot framework or LabVIEW)
Good knowledge on Network Tools – Vector CANoE / CANalyzer, Test Simulation, Measurement and Trace Debugging.
Understanding on Software Test Life Cycle phases (CMM/CMMi) and methodologies (Agile, V Model)
Knowledge on process and able to demonstrate how it has been deployed in projects worked.
Knowledge on Requirement Management Tools (Ex: DNG) Defect Management tool JIRA
Knowledge on Tools for Configuration Management, Defects Management, Peer Reviews of Requirements and Test procedures.
Involved in Test Case Design for Requirements and should have developed Manual /Automated Test Procedures.
More Good Reasons to Work for Visteon Focusing on the Future
Our company strategy focuses on leading the evolution of automotive digital cockpits and safety solutions. This strategy is driven by constant innovation, and you will support our efforts through your role. We are recognized across the industry for innovation. We have a strong book of business that is expected to drive future growth, along with a customer base that includes almost every automotive manufacturer in the world.
Company Culture
Working at Visteon is a journey in which our employees can develop their strengths and advance their careers while making a difference globally. Join us and help change the world and how we interact with our vehicles. Visteon is where the best technical talent creates the future. Learn more about our culture
About Visteon
Visteon is a global technology company serving the mobility industry, dedicated to creating a more enjoyable, connected and safe driving experience. The company’s platforms leverage proven, scalable hardware and software solutions that enable the digital, electric, and autonomous evolution of our global automotive customers. Visteon products align with key industry trends and include digital instrument clusters, displays, Android-based infotainment systems, domain controllers, advanced driver assistance systems and battery management systems. The company is headquartered in Van Buren Township, Michigan, and has approximately 10,000 employees at more than 40 facilities in 18 countries. Visteon reported sales of approximately $2.8 billion and booked $5.1 billion of new business in 2021.Learn more at .