Long-Term Contract Position Summary We are seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical manufacturing facilities, utilities, equipment, and computerized systems. The ideal candidate will have strong experience in GMP-regulated environments and will be responsible for ensuring that manufacturing systems are designed, installed, tested, and operated in compliance with FDA, cGMP, and regulatory requirements. The CQV Engineer will work closely with Engineering, Quality Assurance, Validation, Manufacturing, and external vendors to execute qualification protocols and support project milestones within pharmaceutical production environments. Key Responsibilities Execute commissioning, qualification, and validation activities for pharmaceutical manufacturing equipment, utilities, facilities, and process systems. Develop, review, and execute validation lifecycle documentation including: Validation Master Plans (VMP) User Requirement Specifications (URS) Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Commissioning Protocols and Reports Traceability Matrices Support startup and commissioning activities for new equipment and facility expansions. Perform risk assessments and gap analyses to ensure compliance with regulatory requirements. Review engineering documentation including P&IDs, equipment drawings, specifications, and turnover packages. Coordinate protocol execution with Manufacturing, Engineering, Quality, and Project teams. Investigate deviations encountered during qualification activities and assist with CAPA implementation. Support change control activities and assess validation impact. Ensure compliance with FDA, c
GMP, GAMP
5, ISPE, and company quality standards. Participate in FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) activities. Generate summary reports and provide recommendations for equipment release. Support audits and regulatory inspections as required. Required Qualifications Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline. 3+ years of CQV/Validation experience within pharmaceutical, biotechnology, or medical device manufacturing environments. Strong knowledge of FDA regulations, cGMP requirements, and validation lifecycle principles. Hands-on experience authoring and executing
IQ/OQ/PQ
protocols. Experience qualifying manufacturing equipment, clean utilities, and facility systems. Ability to interpret engineering drawings, P&IDs, and technical specifications. Experience with deviation investigations, change controls, and CAPA processes. Strong documentation and technical writing skills. Excellent communication and cross-functional collaboration abilities. Preferred Qualifications Experience supporting sterile, aseptic, biologics, vaccine, or API manufacturing facilities. Knowledge of ISPE Baseline Guides and ASTM validation standards. Experience with computerized system validation (CSV) and data integrity requirements. Familiarity with DeltaV, SCADA, MES, BMS, EMS, and automation systems. Previous experience supporting large capital projects and facility expansions.
