Project Engineer (Aseptic Pharma Manufacturing Environment)
We are seeking a highly skilled Project Engineer to join our client's high-performing Engineering team in Westport, Co. Mayo.
Job Role Purpose:
The Project Engineer is responsible for safely coordinating and leading projects associated with process improvements, automation, aseptic processing, new processing equipment, and facility/utilities modifications.
Responsibilities:
* Safely coordinate and lead cross-functional project teams for the delivery of processing equipment to the site based on planned timelines and scope.
* Selecting vendors and completing vendor evaluation matrix.
* Writing RCEs, placing orders, project management & design review meetings.
* Working to the ASME BPE 2019 Standard and relevant ISPE Guidelines etc.
* Coordination of processing equipment installation and services hook-up, working with equipment vendors and engineering personnel.
* Lead the project team participation in factory acceptance testing program.
* Coordination of all equipment documentation requirements.
* Commissioning of equipment and engineering support during qualification.
Requirements:
* Third-level qualification in an engineering or equivalent discipline/experience.
* Experience of working in biologics, pharmaceuticals, or medical device industry.
* Min of 2 to 5 years' experience.
* Project management experience with proven record.
Candidate Profile:
Ideally seeking candidates holding qualifications in Mechanical/Electrical/Mechatronic Engineering with at least 3 years' experience in a Pharma/Med Device Project Engineering or Process Engineering role with proven project management experience in a regulated manufacturing environment.