Commissioning, Qualification & Validation (CQV) Engineer

Job Description

We are looking for a highly skilled CQV Engineer to support commissioning, qualification, and validation (CQV) activities for Injectable and Biologics Process Equipment , HVAC, Utility Systems , and pharmaceutical manufacturing processes. The ideal candidate should have experience in validation lifecycle, equipment qualification, risk assessments, and GMP compliance , with strong expertise in document review and execution . Key Responsibilities: Develop and execute CQV documentation such as CQMP, VMP, FRA, cGMP review sheets, and interdependencies . Prepare and execute qualification protocols ( IQ, OQ, PQ ), SOPs, process validation, and cleaning validation protocols . Perform risk assessments (SCA/SLIA, CLIA, SRA/QRA) and ensure compliance with cGMP regulations . Conduct commissioning and validation activities for Injectables, Biologics, API, Fill/Finish, and OSD pharmaceutical process equipment . Perform HVAC and Utility Systems commissioning and qualification . Work with process equipment including PFS, Cartridge, Vial, Isolators, Lyophilizer, Inspection Lines, and Packing Lines . Review, analyze, and interpret system performance data , preparing final report packages . Handle deviations, discrepancies, investigations, CAPA , and ensure ALCOA principles are followed. Ensure compliance with regulatory requirements , including GDP practices . Draft and review equipment operation SOPs and validation-related documentation. Utilize ValGenesis software for qualification activities (preferred). Work collaboratively within project teams and interact with regulatory bodies as needed. Required Qualifications & Skills: Bachelors/Masters degree in Chemical/Pharmaceutical Engineering or related field. 4-10 years of experience in validation, quality systems, or engineering in a GMP environment . Strong expertise in Injectable and Biologics Process Equipment validation, HVAC & Utility Systems commissioning . Hands-on experience with equipment qualification and commissioning protocols . Experience with validation lifecycle approach , risk-based validation methodologies , and regulatory compliance (FDA, EU GMP, WHO) . Knowledge of Documentum or Maximo (preferred). Strong analytical, documentation, and communication skills. Proficiency in Microsoft Office tools. Willingness to travel internationally with a valid passport (no legal restrictions).