- Company Name
- QCS Staffing
- Job Title
- CSV C&Q Engineer
- Job Description
-
**Job title:** CSV C&Q Engineer
**Role Summary:**
Lead the development, implementation, and validation of Computer System Validation (CSV) activities for pharmaceutical and biopharmaceutical systems. Acts as subject‑matter expert (SME) across design, commissioning, qualification, and operational phases, ensuring compliance with regulatory standards such as 21‑CFR Part 11, GAMP 5, and EU GMP Annex 1.
**Expactations:**
- Deliver end‑to‑end CSV strategy and documentation for all critical systems.
- Collaborate with IT, automation, and regulatory SMEs to validate system security, audit trails, data integrity, and backup/recovery.
- Ensure risk‑based qualification of sterile, biotech, and single‑use equipment.
- Provide technical leadership during CAPEX commissioning projects and support post‑installation verification.
**Key Responsibilities:**
1. Create and maintain CSV strategy documents aligned with VMP and ISO/IEC standards.
2. Lead design, execution, and reporting of qualification tests: IQ, OQ, PQ, RQ, FDQ, and FDS sequence testing.
3. Coordinate interface and data import/export validation, including PLC and network level checks.
4. Oversee automation testing for EMS (Galaxy), BMS HVAC, and integrated systems (graphics, IO loop, alarms, interlocks, e‑stop, trending, HDS, FDS).
5. Liaise with IT and automation SMEs to ensure system security, electronic records, signatures, access management, and disaster recovery plans are correctly implemented.
6. Review and approve summary reports, ensuring alignment with regulatory audit requirements.
7. Mentor and guide suppliers and internal teams on CSV best practices.
**Required Skills:**
- Extensive experience as lead/SME in International CAPEX commissioning and qualification.
- Deep knowledge of pharmaceutical/biotechnology CSV, including risk‑based qualification, GAMP 5, ISPE, ASTM E2500, and EU GMP Annex 1.
- Proficiency in audit trail, electronic signatures, system security, data integrity, backup/DRP, and system access controls.
- Strong communication, decision‑making under pressure, and leadership abilities.
- Ability to collaborate with senior stakeholders and cross‑functional teams.
**Required Education & Certifications:**
- Third‑level technical qualification in Engineering (or equivalent).
- Certifications or proven experience in GAMP 5, ISPE best practices, or related CSV/validation disciplines.
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