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Expired
  • Location: Cambridge
  • Salary: Competitive Salary plus Benefits
  • Job Type:Permanent

Posted over 2 years ago

  • Sector: Quality
  • Contact: Adrienn Prezenszki
  • Contact Email: adrienn.prezenszki@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2021-07-27
  • Job Ref: V-46961
Do you have at least 1 -2 years’ experience in computer systems validation during placement or commercial environment in the biopharmaceutical industry?

This is a great opportunity to join a cell therapy company located just South of Cambridge, as a Computer System Validation Specialist on a permanent basis. The ideal candidate has a scientific or technical degree together with experience in validating computer systems (LIMS, or BMR, QMS, monitoring systems) or equipment in a GMP environment according to GAMP. This is a great opportunity developing and progressing in a growing organisation.

The role is full time Monday to Friday primarily based on site with occasional ad – hoc basis working from home. The facility has excellent transport links to Central London, London Stansted airport and close to the M11 motorway.

The Role

Based in a team of 6, you will be responsible managing the validation aspects of projects including scheduling work, agree timeline and liaise with other departments. You will be performing computer system validation activities on equipment, facilities and laboratory systems and manage multiple tasks to provide solutions to complex problems. You will be required to author, execute, and report validation activities according to GMP and QMS requirements.

Working in a fast-paced, highly process-driven manufacturing environment, you will encounter a range of technical challenges and opportunities to collaborate with scientific, engineering, quality, and production teams.

Experience

The successful candidate will be a conscientious, attentive individual with experience in GMP from a role in ideally Computer Systems Validation according to GAMP ideally from the biopharmaceutical, ATMP or related industry. You will ideally have a degree in a Scientific discipline or equivalent experience. You must have a good understanding of manufacturing processes, laboratory equipment and computer systems. You must be able to demonstrate reviewing documents and data, writing quality reports as well as ensuring the meticulous checking and qualification of equipment or computer systems. You will need excellent communication and team working skills, with the ability to handle your own workload, organize your own time and follow Standard Operating Procedures (SOPs).