Overview
We are seeking a skilled Project Engineer to coordinate and lead projects focused on new product introductions, process improvements, automation, aseptic processing, and the integration of new processing equipment – including some facility and utility modifications where required.
The primary objective of this role is to ensure all assigned projects are delivered on time, within scope, and within budget. The Project Engineer will report to the Senior Manager, Engineering, who will provide guidance and support to ensure design, equipment, and facility targets are successfully achieved.
Key Responsibilities
* People & Project Leadership
o Safely coordinate and lead cross-functional teams to deliver new or upgraded processing equipment on schedule.
o Processing equipment would include, for example: Autoclaves, RABS and Isolator Filling Machines, LAF Units, Compounding Skids, Vessels, Containment Booths, and Stopper Processing Equipment.
o Prepare User Requirement Specifications (URS) for new equipment.
o Identify and evaluate vendors; complete vendor assessment matrices.
o Prepare project documentation, including RCEs, purchase orders, and project plans.
o Conduct design reviews and manage project meetings.
o Ensure alignment with ASME BPE 2019, ISPE guidelines, and other relevant standards.
o Oversee equipment installation, utilities connections, and service integration.
o Lead the project team through Factory Acceptance Testing (FAT).
o Manage all equipment documentation requirements.
o Support commissioning, qualification, and engineering activities.
o Deliver handover training, coordinate O&M manuals, spare parts lists, and preventive maintenance schedules.
* Product & Process Support
o Contribute to technical problem-solving related to product manufacturing and aseptic filling.
o Drive process improvement and cost-reduction initiatives.
* Communication & Meetings
o Lead regular project review meetings (weekly or bi-weekly) with assigned teams.
o Participate in scheduled department meetings with management as required.
Requirements: Education & Experience
* Third-level qualification in Engineering or equivalent discipline/experience.
* 5 years’ experience within the biologics or pharmaceutical industries.
* 5 years+ of project engineering and/or project management within pharma with experience in general cleanroom equipment (class A, B).
* Proven project management experience with a track record of delivery.
* Strong technical aptitude with a proactive, hands-on approach.
* Excellent interpersonal and communication skills to operate effectively within a multidisciplinary team.
* Demonstrated leadership skills and the ability to coordinate across multiple departments.
To discuss this role in more detail, contact Corné at 0949316002 or corne@dillones.ie for a confidential discussion.
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