Senior CQV Engineer / Validation Lead

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier providing solutions in Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries across Laboratory, Compliance, Computer, Engineering, Project Management, Validation and related services. We are seeking a dedicated individual for the following position. Position Summary The Senior CQV Engineer / Validation Lead will plan, author, execute and complete Commissioning, Qualification, Validation (CQV) and Process Qualification activities across laboratory, manufacturing and process equipment. The role is hands‑on, requiring independent development of validation documentation, execution of qualification protocols, deviation management, result analysis, final reporting and coordination with Engineering, Manufacturing and Quality teams. The resource will support qualification of laboratory instrumentation, biosafety cabinets, labeling systems, filling and capping equipment, process equipment, bioreactors, AKTA systems, freezers, lyophilizers, autoclaves, washers and associated manufacturing systems. Primary Responsibilities Develop Validation Plans and Qualification Strategies for assigned systems. Conduct System Impact Assessments (SIA) and Risk Assessments. Define CQV deliverables, acceptance criteria and testing approaches. Participate in project planning meetings and provide technical CQV guidance. Maintain document tracking systems and status reports for validation deliverables. Protocol Authoring Independently author and revise: FAT Protocols SAT Protocols IQ Protocols OQ Protocols PQ Protocols IOQ Protocols Validation Summary Reports Qualification Traceability Matrices Generate User Requirement Specifications (URS) when required. Develop test scripts, data sheets and supporting qualification documentation. Route documents through review and approval cycles. Protocol Execution Execute IQ, OQ, PQ and IOQ protocols in the field. Perform equipment walkdowns and field verification activities. Coordinate testing with Engineering, Manufacturing, Vendors and Quality. Document test results and supporting evidence. Support FAT and SAT activities as required. Ensure all testing is performed in accordance with approved protocols and GMP requirements. Deviation Management & Final Reporting Identify, document, investigate and resolve deviations encountered during qualification activities. Support CAPAs and Change Controls affecting qualified systems. Analyze qualification results and assess acceptance criteria. Author final qualification reports and validation summary reports. Support system release into GMP operation. Process Qualification & Characterization Perform characterization studies and process qualification activities. Support qualification of: Filling systems Capping systems Cap inspection systems Labeling systems Check‑weighing systems (including Gage R&R activities) Complete fill‑line process operations Generate and execute OQ and PQ protocols. Compile and analyze process qualification data. Documentation Support Develop and revise equipment SOPs. Develop and update manufacturing batch records. Ensure compliance with GMP documentation practices and site procedures. Specific Activities Included in Scope Desktop Printer IOQ CalCheck IOQ Tube Labeler FAT and IOQ BioSafety Cabinet IOQ Filling Line Characterization Capping System Characterization Labeling System Qualification Check Weighing System Qualification and Gage R&R LTP Line OQ and PQ Generation LTP Line OQ and PQ Execution Final Qualification Reporting Equipment SOP Development Batch Record Development These activities are based on the currently identified CQV work packages and may be adjusted as project priorities evolve. Required Qualifications Bachelor’s Degree in Engineering, Life Sciences or related technical discipline. Minimum 8–10 years of CQV, Validation, Qualification or Process Validation experience within pharmaceutical, biotechnology or medical device environments. Demonstrated experience authoring and executing IQ/OQ/PQ protocols. Strong knowledge of GMP regulations, FDA guidance, ASTM E2500, GAMP and ISPE methodologies. Experience managing deviations, investigations, CAPAs and Change Controls. Strong technical writing skills. Ability to work independently with minimal supervision. Preferred Experience AKTA Systems Bioreactors Biosafety Cabinets Autoclaves and Washers Labeling Systems Filling and Capping Equipment Laboratory Instrumentation Calibration Systems Freezers and Controlled Temperature Equipment Work Location Remote and On‑Site Activities Remote Activities Validation Planning Protocol Authoring URS Development SOP Development Batch Record Development Final Report Preparation Data Review and Analysis On‑Site Activities Equipment Walkdowns Protocol Execution FAT/SAT Support OQ/PQ Execution System Release Activities Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status or disability status. #J-18808-Ljbffr Veg Group