CSV Commissioning and Qualification (C&Q) Engineer
We are seeking an experienced and driven Senior CSV C&Q Engineer to join a high-performing, integrated project team in the pharmaceutical sector. This is a transversal role across GMP equipment, where you will act as the CSV C&Q Subject Matter Expert, leading the validation strategy and ensuring all commissioning and qualification activities are executed safely, on schedule, and in full compliance with system requirements and project procedures.
🔧 Key Responsibilities:
Serve as the CSV C&Q SME and Compliance Lead, providing expert guidance to suppliers and internal teams throughout the lifecycle of system validation-from design through field execution to final reporting.
Lead the development and execution of the CSV C&Q strategy in alignment with the CSV Validation Master Plan (VMP).
Ensure compliance with 21 CFR Part 11, including:
- Audit trail integrity
- Electronic records and signatures
- System security and access management
- Data import/export
- Backup and disaster recovery procedures
- Reporting and documentation
Collaborate with IT SMEs and compliance teams to ensure proper implementation and testing at both network and equipment PLC levels.
⚙️ Automation & Process Systems Responsibilities:
Oversee Process Automation aspects for:
- EMS (Galaxy)
- BMS (HVAC/Black Utilities)
- PCS (DCS), SCADA for systems like WFI distribution, clean gas, etc.
Validate and test:
- Graphics/user interfaces
- IO loop tests
- Alarms, interlocks, e-stops
- Communication/power loss scenarios
- Trending and parameter historization
- Interface and control loop testing
- Automation design documentation and configuration verification
- Functional and sequence testing (FDS, CM/EM/Phase, Recipe Management, Batch Analysis)
Coordinate with automation SMEs to ensure correct implementation and testing at both platform and equipment PLC levels.
Validate PCS PLC equipment (e.g., WFI generators, decontamination stations, lab water, filling lines), including:
- Time synchronization
- System-level access control and disaster recovery
Note: IT systems are out of scope for this role.
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