Role Responsibilities

• 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.

Role Requirements:

• 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.