Job Summary
The Project Engineer is responsible for the safe coordination and execution of projects related to:
* New Product Introductions (NPIs)
* Process improvements and automation
* Aseptic processing enhancements
* Installation of new processing equipment, and associated facility/utilities modifications
The primary focus is to ensure all projects are completed on time, within scope, and within budget. This role reports to the Senior Manager of Aseptic Engineering, who will provide technical guidance and support throughout each project.
Key Responsibilities
* Safely lead cross-functional teams to deliver processing equipment (e.g., Autoclaves, RABS/Isolators, LAF units, Compounding Skids, Containment Booths, Stopper Processing Equipment).
* Author User Requirement Specifications (URS).
* Lead vendor selection and evaluation process.
* Write and submit Request for Capital Expenditure (RCE) documentation and participate in purchase processes.
* Conduct project design reviews and manage project milestones.
* Ensure compliance with ASME BPE 2019, ISPE Guidelines, and applicable industry standards.
* Coordinate installation and utility hook-up of new equipment.
* Lead Factory Acceptance Testing (FAT) programs with vendors and project teams.
* Oversee equipment documentation collection and validation readiness.
* Support commissioning, qualification, and handover activities including training, O&M manual collection, PM schedule development, and spare parts coordination.
* Contribute to cross-functional technical forums focused on product manufacturing and aseptic fill challenges.
* Drive process improvements and cost-reduction initiatives through engineering solutions.
* Lead weekly/bi-weekly Project Review Meetings.
* Participate in Tier 1 Engineering Meetings with your manager.
* Ensure timely communication across departments and maintain alignment on project timelines and deliverables.
Requirements
Education & Experience:
* Bachelor’s Degree (or equivalent) in Engineering or a related discipline.
* 2–5 years of experience in Biologics, Pharmaceutical, or Medical Device industries.
* Proven track record in project management and equipment delivery.
Technical & Interpersonal Skills:
* Strong initiative and technical competency in project execution.
* Working knowledge of aseptic processing and cleanroom equipment.
* Familiarity with standards and regulations (e.g., ASME BPE, ISPE, GMP).
* Excellent communication, organizational, and team leadership skills.
* Ability to manage multiple priorities and cross-functional collaborations.
* Self-directed, proactive problem solver with a collaborative mindset.
For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
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