Process Engineer - Waterford 12-month contract
To provide Process Engineering support to existing business as usual daily functions and on-going continuous improvement pre-filled syringe processes.
Key Responsibilities:
* The main area of work is in acting as Process Engineer for project/programs associated with pre-filled syringe operation.
* Process engineer scope of works will involve, but is not limited to:
o Filter test development
o Fill weight cycle development
o Cleaning verification
o Documentation Generation/Execution (e.g., Recipe documents, FMEAs, Protocols, Reports)
o Leading problem-solving investigations for technical issues as well as owning change controls
* Solidify activities on schedule and within the designated timeframe.
* Support day-to-day operations of the syringe filling area through investigations, identify and deliver corrective actions including continuous improvement projects.
* Communicate and liaise with material/component vendors during projects.
* Execute Process Engineering activities to schedule and to the appropriate compliance and safety standards.
* Write Process/Operational Control Strategy documents (detailing control over Critical Process Parameters), Failure Mode Effect Analysis (FMEA) and supporting Operator training.
* Coordinate and ownership of deliverables to meet project timelines and cost.
* Generate hour-by-hour schedules for planning line time and execution of deliverables.
Additional Responsibilities:
* Provide support where required on the existing Aseptic Syringe Filling Line and supporting processes which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi-filling technologies.
* Support commercial manufacturing through delivery of key performance metrics (SQDCI).
* The role may require travel to other Sanofi sites or vendor sites.
* Participate in site GMP regulatory and safety audits.
* Provide technical support to implement process improvements, new product transfers to the site, and production.
Essential Requirements:
* Honours degree in an Engineering discipline.
* Strong problem-solving skills.
* 3 or more years' relevant experience in a highly regulated GMP environment.
* Experience of Sterile Manufacturing Operations would be an advantage.
* Experience in syringe filling would be a distinct advantage.
* Experience in new product introduction would be a distinct advantage.