Commissioning & Qualification Engineer

Summary:
Our Client is a biopharmaceutical company looking to hire a Commissioning and Qualification (C&Q) Engineer for various capital projects. Ensuring 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.
• Generate C&Q planning documents detailing overall strategy for the project.
• Develops the master list of 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&Qsr).
• Manages Daily C&Q coordination meetings.
• Responsible for Overall Tracking and Reporting of C&Q status and risks/issues.
• Ensures Start-up 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).

Qualifications & Experience:

• 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.
• Experience of sterile / biotech equipment within the pharmaceutical industry is 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.