About the Role We are seeking an experienced Project Engineer to lead and coordinate engineering projects in New Product Introductions, Process Improvements, Automation, and Aseptic Processing.
The role will oversee the installation and qualification of processing equipment, ensuring projects are delivered on time, on budget, and to specification.
This is a hands-on role requiring strong project management skills, technical expertise, and the ability to lead cross-functional teams.
Key Responsibilities Project Leadership & Coordination Lead cross-functional project teams to deliver processing equipment including autoclaves, RABS & isolator filling machines, LAF units, compounding skids, vessels, containment booths, and stopper processing equipment.
Develop User Requirement Specifications (URS) and support vendor selection and evaluation.
Manage project documentation, RCEs, orders, and design reviews.
Ensure installation, commissioning, and qualification of equipment is completed in line with standards.
Lead Factory Acceptance Testing (FAT) and handover training, operational manuals, spare parts, and PM schedules.
Process Improvement & Technical Support Contribute to technical problem-solving forums associated with product manufacture and aseptic fill.
Deliver process improvement and cost reduction projects.
Meetings & Reporting Lead weekly/bi-weekly project review meetings.
Attend senior management meetings to report on project progress.
Requirements Education & Experience Degree in Engineering or equivalent discipline5+ years' experience in pharmaceutical, biologics, or medical device industries, preferably in cleanroom environments (Class A & B)Strong project management experience with a proven track record Technical knowledge of aseptic processing, lyophilization, and processing equipment Experience with tech transfers, visual inspection systems, and equipment installation/qualification Skills & Competencies Strong leadership and team collaboration skills Excellent written and verbal communication Planning, organization, and decision-making capabilities Adaptability in a fast-paced, dynamic environment Results-oriented with a proactive approach Receptive to feedback and able to work in a people-centered culture Other Requirements Willingness to travel for design reviews, build inspections, and FATs For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.