- The CQ Engineer reports to the CQ Area Lead and is responsible for the safe and compliant delivery of verification activities for their assigned systems.
- Commissioning and Qualification of API Process Equipment (Reactors, Vessels, Centrifuges, Filters, Dryers), HVAC (AHUs, Flow Hoods, Balancing Air), or Utilities (Clean, Black, Grey).
- Generation of System Traceability Matrices, C&Q Risk Assessments, C&Q plans, test cases and reports.
- Vendor and Contractor coordination and supervision (offsite and onsite).
- Review and acceptance of contractor and vendor handover documentation.
- Acceptance of systems at Mechanical Completion (following walk-down, punchlisting, etc.).
- Safe set-up of systems (PSSR, LOTO, Valve Line-ups).
- Safe energization and start-up of equipment and systems.
- Document generation and execution for assigned systems (FAT, SAT, RV, IV, OV).
- Running recipes, sequences and functional testing via DCS (DeltaV).
- Troubleshooting and resolving design, installation and operational issues for systems under test.
- Project Change Control and Discrepancy Management for assigned systems.
- Handover of systems to User Team.
- Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard.
- BS Engineering or Science (or equivalent experience).
- Minimum 5 years project experience in the commissioning and qualification of pharma API equipment, HVAC Systems or Utilities.
- Knowledge of Small Molecule Unit Operations, Continuous Manufacturing and/or ATEX environments is desirable.
- Self-motivated, proactive approach with a commitment to meet deadlines.
- Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
- Good written and verbal communication skills with both technical and non-technical staff.
- Delta V experience desirable.
- Kneat experience desirable.
|Job Category||CQV Engineer|