Biomedical Engineering jobs

MS&T Validation Engineer - Remote Working - Long Term Contract

Join a leading global biopharmaceutical organisation dedicated to improving patient access to high‑quality medicines. We are seeking a skilled MS&T Validation Expert to support an exciting large scale capital project on a hybrid working basis in Central Europe.

What you'll do:

• Author and review process, and cleaning validation plans, protocols & reports, for initial validation and/or ongoing process verification (OPV).
• Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation and lead the execution of validation activities on the shop floor.
• Participate in the Tech Transfer teams, under project leadership of the Tech Transfer leads, as core member for process validation.
• Actively participate in defining and implementing the validation strategy for production and cleaning process, for both for initial validation and Ongoing Process or Cleaning verification (OPC, OCV) as well as advocacy to the relevant authorities.

What you'll need:

• Extensive relevant experience in biomanufacturing, technical development, MS&T, or quality, with a focus on validation of large scale mammalian or microbial drug substance manufacturing.
• Proven expertise with Process and Cleaning validation in large scale mammalian or microbial Drug substance production facilities.
• BSc. in Pharmacy, Pharmaceutical Technology, Biochemistry, Chemical Engineering, or a related scientific discipline. MSc or equivalent is preferred.
• Understanding of regulatory requirements, process validation, continued process verification, and cGMP.

If this role is of interest, apply now!
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