Description
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 robust 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, pharmaceutic

📌 Engineer, Computer Software Assurance (Bengaluru)
🏢 Masimo
📍 Bengaluru