Process engineer, 3+ yrs exp. (12m, waterford)

Process Engineer, 3+ yrs Exp. (12M, Waterford)

PROCESS ENGINEER with experience of Sterile Manufacturing Operations, Syringe Filling and New Product Introduction required by CareerWise Recruitment for our multinational biopharmaceutical & medical device client in Waterford. Initial 12 month contract on offer.

The PROCESS ENGINEER will have 3+ years experience and work on Projects / Programs associated with pre-filled syringe operations.

NOTE: It is essential that you hold a valid working visa for Ireland.

Scope of works will involve, but is not limited to:

* Leading problem solving investigations for technical issues as well as owning change controls.
* Delivering activities on schedule and within budget.

Responsibilities:

* Supporting day-to-day operations of the syringe filling area through investigations, identifying and delivering corrective actions including continuous improvement projects.
* Communicate and liaise with material/component vendors during project.
* Execute Process Engineering activities to schedule and to the appropriate compliance and safety standards.
* Writing of Process/Operational Control Strategy documents (detailing control over Critical Process Parameters), Failure Mode Effect Analysis (FMEA) and supporting Operator training.
* Coordinating and ownership of deliverables to meet project timelines and cost.
* Generation of hour-by-hour schedules for planning line time and execution of deliverables.
* 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).
* Role may require travel to other 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.

Requirements:

* Honours degree in an Engineering discipline.
* 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.

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

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