Overview
Our Client is seeking a Process Engineer to support capital projects on site, providing technical oversight of Commissioning, Qualification and Validation (CQV) activities. The successful candidate will ensure process requirements, GMP principles and risk-based methodologies are appropriately applied throughout project delivery, maintaining compliance and inspection readiness.
Key Responsibilities
- Provide technical oversight and review of CQV documentation, including commissioning plans, risk assessments, qualification protocols and reports.
- Ensure process requirements are effectively translated into GMP-compliant design and qualification strategies.
- Support the identification, justification and control of critical quality attributes (CQAs) and critical process parameters (CPPs).
- Apply risk-based approaches to determine qualification scope, testing requirements and verification activities.
- Review and approve CQV strategies, plans and lifecycle documentation.
- Challenge and guide project teams, vendors and CQV service providers to ensure regulatory and industry best practice compliance.
- Support design reviews, change controls and deviation investigations from a technical compliance perspective.
- Ensure systems remain in a validated state and support ongoing inspection readiness.
Requirements
- Bachelor's degree in Engineering (Chemical, Mechanical, Electrical or related discipline).
- Minimum 5 years' experience in Commissioning, Qualification and Validation (CQV) within a regulated pharmaceutical environment.
- Strong understanding of pharmaceutical manufacturing processes, CQAs and CPPs.
- Working knowledge of GMP regulations and industry standards, including EU GMP, FDA and ICH guidelines.
- Experience reviewing and approving CQV lifecycle documentation.
- Strong risk assessment, problem-solving and analytical skills.
- Excellent stakeholder management and communication abilities.
- Ability to identify, assess and escalate compliance and quality risks.
