Senior CQV Engineer / Validation Lead

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
• Generate Validation Summary Reports
• Generate Qualification Traceability Matrices
• Develop 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.
• Capture 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

• Support qualification of:
• Filling systems
• Capping systems
• Cap inspection systems
• Labeling systems
• Check-weighing systems (including Gage R&R activities)
• 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.