Duties & Responsibilities
Lead, develop, and execute comprehensive Computer System Validation (CSV) strategies, plans, and protocols (IQ/OQ/PQ) in compliance with FDA and global regulatory requirements.
Oversee validation activities for GxP-regulated computerized systems including ERP, QMS, MES, manufacturing equipment software, data integrity systems, and custom applications.
Ensure systems meet 21 CFR Part 820, 21 CFR Part 11, and ISO 13485 requirements for software validation and electronic records/electronic signatures.
Partner with cross-functional teams (Quality, IT, Engineering, R&D, Manufacturing) to ensure compliant system lifecycle management aligned with GAMP 5 guidelines.
Drive validation documentation creation, review, and approval, ensuring traceability and regulatory readiness.
Ensure systems used in support of GxP activities are validated and maintained appropriately in compliance with applicable FDA, EU and other international regulations
Serve as the SME during internal audits, supplier audits, and FDA/Notified Body inspections regarding CSV and data integrity.
Assess system changes, conduct impact analyses, and ensure controlled execution of validation activities in accordance with established change control procedures.
Maintain strong understanding of data integrity controls aligned with ALCOA+ principles and applicable global guidance documents.
Develop and improve CSV processes, templates, and procedures to enhance compliance, consistency, and operational efficiency.
Participate in change control processes to assess impact upgrades and changes on validated systems; Oversee execution of change actions.
Coordinate and execute periodic reviews of validated systems per defined schedule; support development of remediation plan, if needed.
Minimum & Preferred Qualifications and Experience:
Minimum Qualifications:
5+ years of experience in Computer System Validation within a regulated medical device, pharmaceutical, or biotechnology environment preferred.
Advanced knowledge of and hands-on experience with: 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, GAMP5 guidelines, FDA guidance on risk-based software validation and computer software assurance.
Proven leadership in planning, executing, and documenting validation of enterprise and manufacturing systems.
Strong understanding of data integrity requirements, audit trails, and system security principles.
Experience developing validation documentation including URS, design specifications, traceability matrix, validation plans, IQ/OQ/PQ, summary reports, and controlled procedures.
Excellent analytical, technical writing, and communication skills.
Preferred Qualifications:
Familiarity with: EU MDR, Annex 11 (EU guidelines on computerized systems) and ISO 27001 (Information Security Management).
Hands-on experience with validation of cloud-based or SaaS systems.
Prior experience supporting FDA and Notified Body inspections as a CSV subject matter expert.
Experience developing or enhancing CSV/QMS processes.
Education
Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related technical field required.
Language Requirements:
Advanced English proficiency (written and verbal) required to collaborate effectively with global stakeholders, prepare technical documentation, and participate in regulatory audits and inspections.
Location
This position is located at our Bengaluru, India office.
Skills Required
- Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or related technical field
- 5+ years of experience in Computer System Validation within regulated medical device, pharmaceutical, or biotechnology environments
- Advanced knowledge and hands-on experience with 21 CFR Part 11, 21 CFR Part 820, ISO 13485, ISO 14971, GAMP5, and FDA guidance on risk-based software validation and computer software assurance
- Proven leadership in planning, executing, and documenting validation of enterprise and manufacturing systems
- Strong understanding of data integrity requirements, audit trails, and system security principles (ALCOA+)
- Experience developing validation documentation including URS, design specifications, traceability matrix, validation plans, IQ/OQ/PQ, and summary reports
- Excellent analytical, technical writing, and communication skills, including advanced English proficiency
- Familiarity with EU MDR, Annex 11, and ISO 27001
- Hands-on experience validating cloud-based or SaaS systems
- Prior experience supporting FDA and Notified Body inspections as a CSV SME
- Experience developing or enhancing CSV/QMS processes
Masimo Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Masimo and has not been reviewed or approved by Masimo.
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Healthcare Strength — Comprehensive medical, dental, and vision coverage is offered alongside company‑paid life insurance at 2x salary and long‑term disability coverage. The package reflects broad core health protection.
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Leave & Time Off Breadth — Policies include 15 days of paid vacation to start, up to 10 paid holidays, 40 hours of sick time, and defined paid parental leave components. This structure provides clear, multi‑category time‑off coverage.
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Wellbeing & Lifestyle Benefits — An EAP, corporate discounts, and onsite amenities such as a café, wellness center, and gym are available at certain locations. These perks enhance day‑to‑day support where onsite access exists.
Masimo Insights
What We Do
Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve life, improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown to outperform other pulse oximetry technologies in over 100 independent and objective studies, which can be found at www.masimo.com/evidence/featured-studies/feature. Masimo SET® is estimated to be used on more than 200 million patients around the world each year and is the primary pulse oximetry at all 10 top U.S. hospitals as ranked in the 2025 Newsweek World’s Best Hospitals listing. Additional information about Masimo and its products may be found at www.masimo.com.
