Commissioning & Qualification process Engineer/Lead
7 days ago
Key Responsibilities:
- Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard; re-enforce in meetings, perform periodic field observation and feedback as needed.
- 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
- Report on any proposals for deviating from the C&Q program during doc development and execution to ensure they are addressed and, if agreed on, documented in a timely manner.
- Report issues for escalation where agreed document review and approval (pre and post, where applicable) turnaround times are not being adhered to.
- Report issues for escalation where agreed execution timelines are not being adhered to.
- Report any other issues which need to be escalated when no resolution is clear with the stakeholders internally.
Qualifications and Requirements:
- 8 years minimum C&Q execution experience in the pharmaceutical sector with a minimum of 1 in a C&Q execution leadership role.
- Degree in engineering (M. Sc. / B. Sc.) or equivalent
- Demonstrated leadership and people management skills.
- Knowledge of GMP'S, regulatory requirements, equipment commissioning and qualification.
- Ability to work well in a team environment.
- Able to manage multiple parties and coordination.
- Proficient in the use of DeltaV.
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