- 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. Primary Responsibilities Validation Planning & Risk Assessment
- 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 impacting 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.
- Maintain validation lifecycle documentation.
- Ensure compliance with GMP documentation practices and site procedures.
Specific Activities Included in Scope The resource may be required to author, execute, and report on activities such as: - Desktop Printer IOQ
- Flat Box Labeler IOPQ
- CalCheck IOQ
- Tube Labeler FAT and IOQ
- SureTorque 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
- Lyophilizers
- Autoclaves and Washers
- Labeling Systems
- Filling and Capping Equipment
- Laboratory Instrumentation
- Calibration Systems
- Freezers and Controlled Temperature Equipment
Work Location Remote Activities - Validation Planning
- Risk Assessments
- 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
- Field Verification
- Deviation Resolution
- Characterization Studies
- OQ/PQ Execution
- System Release Activities
