Senior CQV Engineer / Validation Lead
About The Position
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Senior CQV Engineer / Validation Lead Position Summary The Senior CQV Engineer / Validation Lead will be responsible for the planning, authoring, execution, and completion of Commissioning, Qualification, Validation (CQV), and Process Qualification activities associated with laboratory, manufacturing, and process equipment. This is a hands-on role requiring the individual to independently develop validation documentation, execute qualification protocols, manage deviations, analyze results, and prepare final reports while coordinating activities with Engineering, Manufacturing, and Quality teams. The resource will support qualification activities for laboratory instrumentation, biosafety cabinets, labeling systems, filling and capping equipment, process equipment, bioreactors, AKTA systems, freezers, lyophilizers, autoclaves, washers, and associated manufacturing systems.
Requirements
- 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.
Nice To Haves
- AKTA Systems
- Bioreactors
- Biosafety Cabinets
- Lyophilizers
- Autoclaves and Washers
- Labeling Systems
- Filling and Capping Equipment
- Laboratory Instrumentation
- Calibration Systems
- Freezers and Controlled Temperature Equipment
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.
- 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.
- 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.
- Identify, document, investigate, and resolve deviations encountered during qualification activities.
- Support CAPAs and Change Controls impacting qualified systems.
- Analyze qualification results and assess acceptance criteria.
- Author final qualification reports and validation summary reports.
- Support system release into GMP operation.
- 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.
- Develop and revise equipment SOPs.
- Develop and update manufacturing batch records.
- Maintain validation lifecycle documentation.
- Ensure compliance with GMP documentation practices and site procedures.
Benefits
- people always come first
- empowered to do your best work
- bold ideas thrive
- real progress happens
- opportunity to make a meaningful difference
- shaping the future of healthcare and technology
- purpose-driven, supportive team
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What This Job Offers
Job Type
Full-time
Career Level
Senior
