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.

• 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.

• 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.