Senior Process Enginer
Reference: | AMC3212 |
Location: |
Dublin South
|
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
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.