The C&Q Engineer is responsible for performing and coordinating system commissioning & qualification activities from URS through to system handover for PQ.
- Support project qualification planning scheduling and resource management throughout the project lifecycle
- Ensure clients qualification standards and requirements are followed and met
- Prepare execute and compile C&Q activities protocols and reports
- Support the governance of project delivery against the C&Q roadmap
- Responsible for URS/Specification review and updating to drive consistent testable statements
- Conduct commissionability reviews during the project design stage
- Execute system Safe to Start reviews before system energisation
- Coordinate with package design engineers users and contractors to enable timely Right First Time document preparation and execution
- Review contractor-provided C&Q protocols and reports
- Prepare qualification summary reports and manage the Requirements Traceability Matrix (RTM)
- Attend project PDCA and other relevant meetings
- Review and implement lessons learned maintaining a log for the project duration
Qualifications :
- Bachelors or Masters degree in Engineering Life Sciences or a related field with extensive experience in commissioning and qualification (C&Q) activities within the pharmaceutical or regulated industries.
- In-depth knowledge of GMP GEP and GAMP guidelines with a proven track record in managing GMP compliance and quality assurance.
- Proficiency in developing and reviewing C&Q protocols (FATs SATs DQ IQ OQ PQ) and managing Requirements Traceability Matrix (RTM).
- Experience with facilities utilities process equipment and automated systems (GAMP) including conducting commissionability reviews and Safe to Start assessments.
- Strong project management skills including qualification planning scheduling and resource management throughout the project lifecycle.
- Excellent communication skills with the ability to coordinate effectively with package design engineers users and contractors and translate client needs into actionable C&Q requirements.
- Demonstrated ability to prepare qualification summary reports manage project documentation and implement lessons learned.
Additional Information :
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Remote Work :
No
Employment Type :
Full-time