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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Senior Process Enginer


Reference:AMC3212 Location: Dublin South
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Engineer

Senior Process Engineer
AMC3212
Contract – 12 months
South Dublin


We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


You will be working as part of a Process Development Commercial support team responsible for providing process and product support to drug product formulation and fill finish operations on site.


The successful candidate will have 4-6 years engineering experience in GMP environment, an understanding of Lean 6 sigma and at least a BSc in Engineering or Scientific discipline.


Your main responsibilities would include

  • Day-to-day operations support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
  • Product and process investigation support
  • Continuous improvement projects to improve process performance and productivity.

Other Responsibilities:
  • Assess proposed changes to commercial processes under the change control process.
  • Review and approve changes to operating procedures, electronic batch records, and product documentation.
  • Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation.
  • Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support.
  • Risk assessments and mitigation projects relating to line performance.
  • Perform process gap analysis and developing strategies to close gaps.
  • Data trend analysis for all performance aspects of the area.
  • Troubleshooting performance trends.


Requirements
  • BSc in Science or Engineering and 4-6 years experience in GMP manufacturing OR Phd and 3 years experience
  • 4-6 years experience in GMP manufacturing including NPI or process improvement experience
  • Leadership skills and ability to build teams and operate across operational boundaries
  • Lean 6 sigma qualifications or experience
  • New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous.

If interested in this posting please feel free to contact Angela McCauley on +353 (0)87 693 0951 or [email protected] for further information.