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.