Engineer, Computer Software Assurance

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.

• 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.

• 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.

   

• 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.

• This position is located at our Bengaluru, India office.