Our partner is looking for an C&Q Engineer to join its team. This international company is well-known for its pharmaceuticals.
As senior Commissioning and Qualification engineer for a specific system, and as part of an integrated team, you will act as C&Q Subject Matter Expert providing expertise and Lead the C&Q portion of the project for a selected system to ensure the C&Q activities are completed safely, as per schedule and in compliance with the system Requirements, Specifications and project procedures/ guidelines.
Here are your main tasks :
- Draft, or support the document drafting by a partner or supplier, coordinate review and approval of C&Q documents (QRA/DV/RTM/FAT/SAT/IOV/VSR) following approved VMP and SLIA.
- Drive verification testing, protocol execution, walk-downs, verification of system drawings and troubleshoot as required.
- Conduct deviation investigation and resolution for problems and issues encountered during field execution activities.
- Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s).
- Review and accept turnover of equipment / system from construction group.
- Generate and or review change controls related to C&Q and drive their closure in a timely manner.
- Ensures all personnel who perform C&Q activities for the system have relevant training assigned.
- Assist/ facilitate in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Systems.
- You have minimum 5 years experience in International CAPEX Commissioning and Qualification.
- You are fluent in English.
- You have a Technical qualification at third level or equivalent in Engineering.
- Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ ASTM E2500/ electronic execution.
- Experience with Post OQ activities is preferred.
- Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry is preferred.
- Knowledge of safety, GMP and environmental regulatory requirements.
- You demonstrate a strong Communication and Leadership skills.
- Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply.
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