We are currently recruiting a
Project Engineer
to support the delivery of capital and process engineering projects within a regulated manufacturing environment. This contract role will focus on
new product introductions, process improvements, automation and aseptic processing equipment
, ensuring projects are delivered
safely, on time and within budget
.
The
Project Engineer
will work closely with cross-functional teams, equipment vendors, and engineering leadership to deliver high-quality technical solutions that meet business and compliance requirements.
Key Responsibilities
Project & Technical Delivery
* Lead and coordinate cross-functional project teams to deliver new processing equipment and system upgrades.
* Manage projects involving equipment such as autoclaves, aseptic filling systems (RABS/Isolators), LAF units, compounding skids, vessels, containment booths, and stopper processing equipment.
* Develop
User Requirement Specifications (URS)
and support vendor selection through evaluation matrices.
* Prepare RCEs, place purchase orders, and lead design reviews and project management meetings.
* Ensure equipment and system designs align with
ASME BPE (2019)
, ISPE guidelines, and industry best practices.
* Coordinate installation, utilities hook-ups, and site integration with vendors and internal engineering teams.
* Lead
Factory Acceptance Testing (FAT)
activities.
* Manage equipment documentation, commissioning, and provide engineering support during qualification.
* Coordinate handover activities including operator training, O&M manuals, spare parts, and preventative maintenance schedules.
Process Improvement
* Contribute to technical problem-solving related to manufacturing and aseptic operations.
* Deliver process improvement and cost-reduction initiatives.
Communication & Stakeholder Management
* Lead weekly or bi-weekly project review meetings.
* Collaborate closely with Quality, Validation, Operations, Maintenance, Technology, EHS, and IT stakeholders.
* Maintain clear communication with engineering leadership on project status, risks, and milestones.
Requirements
Education & Experience
* Third-level qualification in Engineering or equivalent experience.
* 2–5 years' experience
in Biologics, Pharmaceutical, or Medical Device manufacturing.
* Proven project management experience in a regulated environment.
* Strong technical capability with a hands-on, solutions-focused approach.
Skills & Competencies
* Excellent communication and interpersonal skills.
* Strong planning, organisation, and decision-making ability.
* Comfortable leading cross-functional teams.
* Ability to work independently while contributing effectively within a team environment.
* Adaptable and capable of delivering results in a fast-paced setting.
Additional Information
* Travel may be required for design reviews, vendor visits, build inspections, and Factory Acceptance Testing (FAT).
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.