Commissioning & Qualification Engineer
Tandem Project Management
- Dublin
- Contract
- Full-time
Our client is a biopharmaceutical company based in South Dublin looking for a Commissioning and Qualification (C&Q) engineer for various capital projects. 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:
- Coordinates and Supervises all C&Q activities on their assigned projects.
- Generate C&Q planning documents detailing overall project strategy.
- Develops the master list of project C&Q test documents and activities.
- Generates all C&Q summary reports.
- Ensures the C&Q schedule is developed and maintained.
- Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report)
- Manages Daily C&Q coordination meetings.
- Responsible for Overall 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 (URS's) and Quality.
- Risk Assessment for Equipment and Automated Systems (QRAES).
- 6+ years' experience in Engineering or Commissioning and Qualification Management.
- Technical qualification at third level or equivalent in Engineering.
- Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred.
- Knowledge of safety, GMP and environmental regulatory requirements.
- Demonstrated strong Communication and Leadership skills.
- Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
- Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.