We are currently seeking an experienced Commissioning, Qualification, and Validation (CQV) Engineer for a high-impact, short-term contract based in Athlone. Joining a fast-paced capital projects team, you will play a critical role in ensuring equipment lifecycle projects meet the highest standards of safety, compliance, and performance within a sterile manufacturing environment.
Position Overview
As a CQV Engineer, you will lead validation activities for Sterile Fill-Finish equipment. Your primary focus will be to ensure all systems are qualified in strict accordance with GMP and Quality requirements, maintaining peak operational performance and regulatory alignment throughout the project lifecycle.
Key Responsibilities
- Validation Lifecycle Management: Provide end-to-end technical support from initial design and URS development through to qualification and periodic reviews.
- Strategic Planning: Develop qualification approaches and equipment family strategies; draft and approve Validation Plans, FAT, SAT, IV/FTs, and IOQ/PQs.
- Specialized Oversight: Manage validation for vial and syringe filling, formulation, inspection, and utility systems.
- Safety & Coordination: Lead the safe, coordinated startup of new equipment and utilities.
- Cross-Functional Liaison: Collaborate with Engineering, Manufacturing, and external vendors to ensure Quality by Design (QbD) principles are integrated into all specifications.
- Risk & Compliance: Facilitate Quality Risk Assessments (QRAES) and ensure all activities align with ICH/ASTM guidelines and site change control procedures.
- Audit Readiness: Participate in regulatory inspections, contribute to filings, and handle Responses to Questions (RTQs).
- Process Improvement: Update Standard Operating Procedures (SOPs) and support New Product Introductions (NPI) into existing equipment lines.
Education & Experience Requirements
- Expertise: 6+ years of hands-on experience in Science, Engineering, or CQV Management within the Pharma/Biotech sectors.
- Education: Third-level technical qualification (Degree or equivalent) in an Engineering or Science discipline.
- Technical Knowledge: Extensive experience managing C&Q for large-scale Biotech projects with a strong grasp of risk-based approaches.
- Industry Specifics: Proven track record qualifying sterile filling, formulation, and utility systems for drug products.
- Regulatory Savvy: Deep understanding of GMP, safety, and environmental regulations.
- Collaboration: Proven ability to work effectively within multidisciplinary teams and cross-functional investigation units.
Contract Details
- Duration: 3 Months
- Location: Athlone, Ireland
- Environment: Sterile Manufacturing / Fill-Finish
