- Development of design phase C&Q documentation such as FRA, DREV, DQ, SRA, QP etc. for Biopharmaceutical Process Equipment systems within schedule requirements.
- Lead a team as the system owner in preparing and executing Biopharmaceutical Process Equipment C&Q documents, ensuring achievement of the project schedule, track and report progress to the C&Q Manager.
- Provide a strong working technical knowledge of Biopharmaceutical Process Equipment systems regarding the development of protocols, their execution, and close out.
- Provide technical oversight to a Biopharmaceutical Process Equipment C&Q team to assure technical work quality, consistency, and alignment with the C&Q programme.
- Work in the Kneat platform for preparation, review and approval of C&Q documentation with a key focus on traceability to User Requirements throughout.
- Coordinate with the Engineering Compliance team, the QA team and other stakeholders in assuring all decisions on the document preparation for Biopharmaceutical Process Equipment systems are aligned and agreed.
- Work collaboratively with the other project disciplines (e.g. automation, construction, engineering, end user) to support integration of activities.
- Train Biopharmaceutical Process Equipment personnel on the C&Q programme and it’s implementation in execution.
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