Job Description
Key Responsibilities
- Plan, coordinate and execute full lifecycle validation of computerized systems, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
- Develop and maintain validation deliverables: plans, protocols, test scripts, traceability matrices, summary reports
- Conduct system risk assessments, create and review URS (User Requirements Specification), functional specifications, and design documentation
- Ensure regulatory compliance with frameworks such as FDA 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 13485, IEC 62304, GLP/GMP/GCP as applicable
- Collaborate with IT, QA, R&D, and business units to manage change controls, deviations, and re-validation efforts
- Prepare documentation for and support internal/external audits and inspections; address regulatory inquiries
- Conduct periodic system reviews and decommissioning/retirement activities as needed
- Provide training to stakeholders on validated systems and compliance practices
Qualifications & Experience
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field
- 2–5+ years experience in computer system validation within regulated industries (medical devices, pharmaceuticals, biotech)
- Familiarity with validation methodologies: risk-based validation, GAMP 5, and SDLC
- Strong knowledge of data integrity principles and project management tools
- Excellent written and verbal communication abilities; strong analytical and documentation skills
- Experience integrating and validating systems like ERP, LIMS, MES, Lab X, UV‑Vis, FTIR, or similar is a plus
- Professional certifications (ASQ, ISPE, etc.) are advantageous
Regulatory & Technical Knowledge
- Deep understanding of FDA CFR Title 21, EU Annex 11, ISO 13485, IEC 62304, GLP/GMP/GCP, and Gx P principles
- Awareness of medicinal and medical device regulatory standards and industry best practices
Preferred Attributes
- Strong organizational skills with attention to detail
- Ability to work collaboratively in cross-functional teams
- Experience with audit readiness and remediation activities
- Desire for continuous improvement and staying current with regulatory trends
- Plan, coordinate and execute full lifecycle validation of computerized systems, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
- Develop and maintain validation deliverables: plans, protocols, test scripts, traceability matrices, summary reports
- Conduct system risk assessments, create and review URS (User Requirements Specification), functional specifications, and design documentation
- Ensure regulatory compliance with frameworks such as FDA 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 13485, IEC 62304, GLP/GMP/GCP as applicable
- Collaborate with IT, QA, R&D, and business units to manage change controls, deviations, and re-validation efforts
- Prepare documentation for and support internal/external audits and inspections; address regulatory inquiries
- Conduct periodic system reviews and decommissioning/retirement activities as needed
- Provide training to stakeholders on validated systems and compliance practices
Qualifications & Experience
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field
- 2–5+ years experience in computer system validation within regulated industries (medical devices, pharmaceuticals, biotech)
- Familiarity with validation methodologies: risk-based validation, GAMP 5, and SDLC
- Strong knowledge of data integrity principles and project management tools
- Excellent written and verbal communication abilities; strong analytical and documentation skills
- Experience integrating and validating systems like ERP, LIMS, MES, Lab X, UV‑Vis, FTIR, or similar is a plus
- Professional certifications (ASQ, ISPE, etc.) are advantageous
Regulatory & Technical Knowledge
- Deep understanding of FDA CFR Title 21, EU Annex 11, ISO 13485, IEC 62304, GLP/GMP/GCP, and Gx P principles
- Awareness of medicinal and medical device regulatory standards and industry best practices
Preferred Attributes
- Strong organizational skills with attention to detail
- Ability to work collaboratively in cross-functional teams
- Experience with audit readiness and remediation activities
- Desire for continuous improvement and staying current with regulatory trends
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