C&Q Engineer

2 days ago


Dublin, Ireland Tandem Project Management Ltd. Full time

Summary:

Our client is a biopharmaceutical company currently expanding its facility and is looking for a Clean Utilities C&Q Engineer who will own projects, equipment and be responsible for document drafting and protocol execution. The successful candidate will ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Responsibilities:

- Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation.

- Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report.

- Provide technical assistance during investigations and system design.

- Coordinates and Supervises all C&Q activities on their systems.

- Ensures the C&Q schedule is maintained.

- Manages daily C&Q coordination meetings.

- Responsible for tracking and reporting of C&Q status and risks/issues.

- Ensures startup of equipment/utilities is completed in a safe and coordinated manner.

- Assist in the development of User Requirement Specifications (URSs) and Quality.

- Risk Assessment for Equipment and Automated Systems (QRAES).

Qualifications & Experience:

- Technical qualification at third level or equivalent in Engineering.

- 6+ years’ experience in Engineering or Commissioning and Qualification Management.

- Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred.

- Knowledge of safety, GMP and environmental regulatory requirements.

- Strong understanding of a risk‐based approach to commissioning and qualification within the biotechnology industry.

- Familiarity with paperless validation systems.

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