Seeking an experienced engineer to lead the commissioning and qualification (C&Q) of clean utility systems for capital projects. This role ensures all C&Q activities are executed efficiently, adhering to safety standards, timelines, and regulatory compliance, particularly GMP and quality protocols.
Key Responsibilities:
- Oversee commissioning and qualification processes for clean utility systems, ensuring compliance with required documentation.
- Develop comprehensive C&Q documentation, including test plans, validation protocols, and final reports (e.g., C&Q Plans, FAT/SAT, IV/FT, and summary reports).
- Provide technical expertise in system design and troubleshooting during investigations.
- Lead and coordinate all C&Q activities for assigned projects, ensuring seamless execution.
- Maintain project schedules and facilitate daily coordination meetings to track progress.
- Monitor and report on C&Q status, identifying potential risks and implementing solutions.
- Ensure equipment and utility start-up processes are carried out safely and efficiently.
- Support the creation of User Requirement Specifications (URS) and Quality Risk Assessments (QRAES) for equipment and automated systems.
Qualifications & Experience:
- Minimum of 6 years' experience in engineering or C&Q management.
- Bachelor's degree (or equivalent) in Engineering or a related technical field.
- Proven expertise in managing commissioning and qualification activities within the pharmaceutical or biotechnology industries.
- In-depth knowledge of GMP, safety regulations, and environmental compliance standards.
- Strong leadership and communication skills, with the ability to engage senior stakeholders effectively.
- Solid understanding of risk-based approaches to commissioning and qualification in biopharma settings.
- Experience working with paperless validation systems is an advantage.