Engineer, Computer Software Assurance
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Job Description
Job Description
Duties & Responsibilities
Minimum & Preferred Qualifications and Experience:
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:
- 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.
- 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.
More Info
Job Type:
Industry:
Employment Type:
Key Skills
21 CFR Part 820
FDA guidance on risk-based software validation
data integrity controls
GAMP 5
About Company
Skills:
Exploratory Testing, Pytest, Mobile Device Testing, Agile Methodologies, Python, Iso 13485, scenario-based manual testing, IEC 62304, Boundary Value Analysis, Playwright, test design techniques, Decision Table Testing, end-to-end testing, Equivalence Partitioning, Error Guessing, State Transition Testing
Skills:
Design History File Compilation, Technical File Documentation, Design Verification, Quality Tools, usability engineering, Statistical Methods, Risk Management, Post Market Surveillance, ISO 13485 Quality Standard, Complaint Investigation, MDD, IEC EN 62366, 21 CFR 4 Regulation of Combination Products, Quality Risk Management, Process Qualification and Validation, Corrective Action and Preventive Action System, MDR, Test Procedure Development, Design Control Activities, ANSI HE75 Human Factors Engineering
Skills:
Iso 14971, Collaboration, IEC 62366-1, usability engineering, human factors engineering, Risk Management, Technical Writing
Skills:
Quality Management System (QMS, Atlassian Tools (JIRA, Confluence, Test Automation, Bamboo, Verification And Validation, Software Testing, System Testing, Test Engineering, AWS, Redis, Python, Azure, Mongo, Cloud Infrastructure Verification, AMQ, Iso 13485, Iso 14971, Helix Jama, Polarion, GPI Databases, Cloud Certificates, IEC 60601, IEC 62304, Salesforce applications, Aurora
Skills:
complaint investigations , regulatory audits , Technical documentation systems, Iso 13485, fmeca, Post-market surveillance, Fmea, quality engineering, Root cause analysis tools, ISO 14971 risk management frameworks, Medical device systems engineering, Data analysis tools, Complex electromechanical devices, Hazard Analysis, NCR CAPA and deviation management systems, Complaint handling and investigation workflows, 21 CFR Part 803 Medical Device Reporting, Robotic medical device experience, Adverse event investigations, fault tree analysis, FDA inspections, 21 CFR Part 820 QSR