CQV Engineer

The CQV Engineer (Formulation) is responsible for commissioning, qualification, and validation activities for formulation process equipment and associated utilities within a GMP-regulated environment. This includes ensuring that all systems meet user requirements, functional specifications, and quality standards, with a primary focus on safety, regulatory compliance, and successful project delivery for the following equipment:

Key Responsibilities

• Develop and execute CQV protocols (SAT, IQ, OQ, PQ) for all relevant equipment.
• Coordinate and supervise commissioning and qualification activities in accordance with cGMP and corporate policies.
• Generate and review CQV deliverables (user requirements, functional/design specifications, traceability matrices, test scripts, deviation reports).
• Liaise with vendors and contractors for FAT, SAT, and punch list resolution.

Equipment & Systems in Scope

• CIP Skids and docking stations
• Isolator systems (including hopper and integrated weighing systems)
• Glove tester isolators
• Ventilated Balance Enclosure (VBE)
• Precision weighing scales
• Formulation vessels, inline blenders, and disperser units
• Docking Stations (general and for Solvent Distribution, including Down Flow Booths)
• Particle Filter Skids and Sterile Filter Skids
• Filter Integrity Tester units
• Pass-through chambers
• Heating jackets (for drums and vessels)

Project & Quality Support

• Support project delivery teams, vendors, and site stakeholders during design, installation, and start-up phases.
• Ensure equipment meets regulatory and safety standards.
• Participate in risk assessments (e.g., FMEAs), HAZOPs, and design reviews.
• Support generation and remediation of deviations, discrepancies, and change controls.
• Maintain project documentation in line with Data Integrity principles.

Operational Readiness & Handover

• Assist the transition of qualified systems to operations/production teams.
• Provide technical training, SOP review, and troubleshooting during handover.

Required Qualifications / Skills

• Bachelor’s degree in Engineering (Chemical, Mechanical, Process, or related discipline).
• 5+ years’ experience as a CQV Engineer or similar role in the pharmaceutical, biotech, or related regulated industry.
• Proven experience with formulation systems and relevant process/utility equipment.
• Strong knowledge of cGMP, FDA, and EU regulatory requirements pertaining to commissioning and qualification.
• Experience with protocol generation & execution, deviation management, and technical writing.
• Good problem-solving skills and ability to work effectively in cross-functional teams.