Job Description
A Process Engineer is required by CareerWise Recruitment for our Waterford based Pharmaceutical Client. This is a 12-month contractor position. If you are interested in working in a Sterile environment working and supporting technical transfers then this is the position for you
Role of this position
1. Deliver projects works under the bracket of continuous improvement in the existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to support NPI and capacity expansion including but not limited to single use technology vendor selection, component introduction and qualification.
2. Execute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standards.
3. Provide support on the existing Aseptic Syringe Filling Lines which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
4. Support commercial manufacturing through delivery of key performance metrics (SQDCI). Support and participation in Regulatory Audits
JOB REQUIREMENTS
5. Degree in an Engineering discipline.
6. Strong problem-solving skills.
7. Strong documentation/protocol generation and execution skills.
8. 3 or more years' relevant experience in a highly regulated GMP environment
9. Experience in syringe filling would be a distinct advantage.
10. Ability to lead major investigations
11. Fill Weight Cycle Development experience for a filling machine
12. New product introduction experience to a sterile manufacturing