We are seeking a high-caliber CQV Engineer to join a dynamic team overseeing capital and equipment lifecycle projects within a leading-edge sterile manufacturing facility. This role is pivotal in ensuring that complex equipment-specifically within Vial and Syringe Fill-Finish-is commissioned and validated to the highest safety, GMP, and quality standards.
Key Responsibilities
- Full Lifecycle Management: Lead validation activities from initial design and URS development through to SAT, IOQ, PQ, and periodic reviews.
- Strategic Planning: Develop equipment family strategies and Quality Risk Assessments (QRAES) for automated systems and utilities.
- Cross-Functional Collaboration: Partner with Engineering, Manufacturing, and external vendors to ensure Quality by Design (QbD) principles are integrated from FAT to final handover.
- Regulatory & Compliance: Act as a subject matter expert during regulatory inspections and filings, ensuring all documentation aligns with ICH/ASTM guidelines and site SOPs.
- Operational Excellence: Support New Product Introductions (NPI) and drive continuous improvements within the equipment validation lifecycle.
Candidate Profile
- Experience: 6+ years in CQV, Engineering, or Validation within the Pharma/Biotech sector.
- Technical Expertise: Proven track record qualifying sterile formulation, filling, and inspection systems.
- Regulatory Knowledge: Deep understanding of a risk-based approach to commissioning and a firm grasp of current GMP and safety requirements.
- Education: Third-level technical degree (Level 7/8+) in Engineering, Science, or a related discipline.
- Soft Skills: A collaborative mindset with the ability to lead cross-functional investigation teams and manage complex vendor relationships.
