Process Optimization Specialist

5 days ago


Nenagh, County Tipperary, Ireland Life Science Recruitment Ltd Full time

**Job Summary:**

We are seeking a Process Optimization Specialist to join our client's team on a permanent basis.

The ideal candidate will have extensive experience in tech transfer and commercial manufacturing.

This role offers flexibility to work remotely and involves some travel.

Main Responsibilities:

  • Lead the review of all GxP manufacturing and packaging documentation from contract manufacturing sites
  • Support dossier compilation and review for all new drug products
  • Liaise with other internal departments to ensure timely implementation of necessary manufacturing documentation
  • Perform CPV and identify trends
  • Implement changes identified from CPV, cGMP standards requirements, process improvements or corrective actions
  • Prepare, review and approve SOPs
  • Conduct and support manufacturing process investigations to drive operational excellence and continuous improvement
  • Evaluate new suppliers from a technical manufacturing perspective

Requirements: B.Sc. in a science related discipline (Chemistry, Engineering, Biotechnology, Pharmacy etc.) and 10 years relevant experience in a cGMP pharmaceutical manufacturing environment.

Key Requirements:

  • Experience in multiple manufacturing process areas such as technology/product transfer, process scale up, process optimisation, process validation and routine manufacture
  • Extensive manufacturing experience with multiple dosage forms including but not limited to sterile, oral liquid and solid oral dosage products
  • On floor/in plant experience required


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