Overall Purpose:
Process Engineer required to work within the Process Development Commercial Support team based in Dublin. The team is responsible for providing process and product support to drug product formulation and fill-finish operations as drug product process SMEs
Key responsibilities:
- Day-to-day operations support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
- Key contributor to product and process investigations, responsible for assessing product and process impact
- Leads continuous improvement projects to improve process performance and productivity.
- The successful candidate will be be involved in activities such as (but not exclusively);
- Assess product impact associated with proposed changes to commercial processes under the change control process.
- 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.
Basic Qualifications:
- Bachelor's or Masters degree in Engineering, Science or related discipline with 6 years experience in a similar role OR PhD and 3 years of directly related experience.
- Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
Preferred Qualifications:
- 4+ years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilization
- Qualification in Lean and 6-sigma methodologies would be an advantage.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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