Commissioning and Qualification Engineer
We are seeking an experienced Commissioning and Qualification Engineer to join our team at {company}. This role is ideal for professionals who want to work with a leading multinational in the biopharmaceutical industry.
Key Responsibilities:
* Coordinate and supervise all C&Q activities.
* Develop C&Q planning documents detailing overall project strategy.
* Generate master lists of C&Q test documents and activities.
* Produce comprehensive C&Q summary reports.
* Ensure timely development and maintenance of the C&Q schedule.
* Generate C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Qsr).
* Manage daily C&Q coordination meetings.
* Track and report on C&Q status, risks, and issues.
* Ensure safe and coordinated startup of equipment and utilities.
* Contribute to User Requirement Specifications (URS's) and Quality development.
Requirements:
* 6+ years of 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 with sterile/biotech equipment in the pharmaceutical industry is preferred.
* Familiarity with safety, GMP, and environmental regulatory requirements.