CQV Engineer

Responsibilities

• Prepare high-level documents, including System Risk Assessments (SRA): draft for review, incorporate feedback, and obtain approval.
• Prepare Design Qualification (DQ) protocol drafts for review, incorporate comments, and obtain pre-execution approval. Execute approved DQ protocols, identify non-conformances to User Requirements Specifications (URS), and prepare DQ summary reports.
• Draft the Requirements Traceability Matrix (RTM), incorporate feedback, and obtain approval.
• Review and provide comments on pre-execution vendor commissioning protocols. Witness protocol execution, ensure testing is completed, and record results in accordance with Good Documentation Practices (GDP).
• Draft Installation, Operational, and Performance Qualification (IOQ) protocols; issue for review; and obtain pre-execution approval. Execute IOQ protocols, manage and close deviations, and prepare summary reports upon completion of OQ (or PQ, where applicable).
• Draft Performance Qualification (PQ) protocols, issue for review, and obtain pre-execution approval.
• Execute PQ protocols, manage and close deviations, and prepare PQ summary reports upon completion.

Knowledge, Skills and Abilities

• Experience in writing and/or executing Commissioning & Qualification (C&Q) protocols and associated documents, including Risk Assessments, Design Qualification (DQ) protocols, Requirements Traceability Matrix (RTM), Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols, Deviations, Qualification Summary Reports

• Ability to apply a science- and risk-based approach to C&Q in line with ISPE Baseline Guide Volume 5: Commissioning & Qualification (2nd Edition, October 2019) and ISPE GAMP 5 methodology

• Knowledge of HSA, PIC/S, and US FDA cGMP CQV/CSV regulations is advantageous, though not mandatory.

Preferred Experience and Skills

• Bachelor’s degree in Biotechnology Engineering, Chemical Engineering, or a related field.
• Ability to work in a fast-paced, regulated environment.
• Strong planning, scheduling, organizational, prioritization, and project coordination skills.
• Strong understanding of facilities systems validation and GMP requirements.