Job Summary
We are seeking a Clean Utilities Commissioning and Qualification (C&Q) Engineer to support various capital projects within the pharmaceutical or biotechnology industry. The role involves leading clean utilities commissioning and qualification efforts, overseeing FAT/SAT activities, and managing vendor coordination, documentation, and design validation.
Responsibilities
- Lead commissioning and qualification (C&Q) activities for clean utility systems, including purified water, clean steam, and process utilities.
- Generate and execute C&Q documentation, such as C&Q Plans, FATs, SATs, and qualification reports.
- Collaborate with vendors to ensure design documents and testing protocols meet project requirements.
- Conduct mechanical walkdowns and coordinate system startup activities.
- Manage C&Q schedules, daily coordination meetings, and risk tracking.
- Oversee system design reviews and provide technical input during investigations.
- Ensure compliance with GMP, regulatory standards, and safety requirements.
- Support the development of User Requirement Specifications (URS) and Quality Risk Assessments (QRAES).
- Utilise online validation systems (e.g., KNERT) for paperless documentation and reporting.
Qualifications
- A technical qualification in engineering or equivalent (third level or higher).
- At least 3-4 years of experience in clean utilities commissioning or related roles.
- Familiarity with clean utility systems, such as purified water, clean steam, or whiffy tanks.
- Experience with FAT/SAT processes, vendor documentation, and testing protocols.
- Strong understanding of GMP regulations and risk-based commissioning practices.
- Knowledge of microbial testing and regulatory requirements for clean utilities.
- Experience with process equipment (e.g., isolators, fillers, autoclaves, or parts washers) is advantageous.
- Proficiency in paperless validation systems is desirable.
- KNERT experience (online validation systems).
- Exposure to multiple process equipment types (e.g., fill lines, formulation equipment).
- Demonstrated ability to manage system ownership from design to implementation.
This role requires a detail-oriented professional capable of managing complex C&Q activities while working collaboratively with vendors and internal teams.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
