Website:
continuousintelligence.ai
Job details:
Job description:
The GxP Consultant / Client-Facing Validation Engineer is responsible for delivering end-to-end validation and compliance consulting services to pharmaceutical, biotechnology, and medical device clients.
This role combines Computer System Validation (CSV) with Equipment, Utilities, and Facilities Qualification, ensuring compliance with global regulatory standards including U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), 21 CFR Part 11, EU Annex 11, and GAMP 5 principles.
The consultant acts as a trusted client advisor, ensuring systems, processes, infrastructure, and manufacturing assets are validated, audit-ready, and continuously compliant.
Key Responsibilities
- Act as primary validation contact for clients.
- Conduct validation discussions, project status meetings, and workshops.
- Support client audits, inspections, and compliance reviews.
- Execute validation lifecycle activities for GxP systems .
- Prepare validation documentation including:
- Validation Plan
- Risk Assessment
- Software Assessment
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- IQ / OQ / PQ Protocols
- Traceability Matrix
- Validation Summary Report
- Support qualification of pharmaceutical manufacturing and laboratory equipment.
- Review FAT/SAT documentation and support equipment validation activities.
- Support qualification of utilities and facilities systems including:
- HVAC systems
- Cleanrooms
- Water systems (PW/WFI)
- Compressed air systems
- Environmental monitoring systems
Change Control Management
- Perform validation impact assessments for system or equipment changes.
- Update validation documentation and testing requirements.
- Support Change Control processes and revalidation activities.
Documentation & eDMS Management
- Manage validation documentation in eDMS platforms.
- Ensure document version control, approval workflows, and audit readiness.
Job Types: Full-time, Permanent
Benefits:
- Flexible schedule
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
Click on Apply to know more.