The Project Engineer will support the delivery of capital and site-based projects within a highly regulated pharmaceutical manufacturing environment, with a strong focus on
clean utility systems and production support infrastructure
. This role is suited to an
intermediate-level engineer
who has developed a solid foundation in GMP environments and is now seeking to broaden their experience across
utilities, process support systems, and equipment projects
.
Key Responsibilities
Project Delivery & Coordination
* Support the execution of equipment, facility, and
clean utility projects
from concept and detailed design through installation, commissioning, and final handover.
* Assist with upgrades and modifications to clean utilities including
WFI, Purified Water, Clean Steam, Clean Compressed Air, process gases, CIP systems
, and supporting infrastructure.
* Support projects involving production and support equipment such as vessels, skid-mounted systems, HVAC, chillers, and building services.
* Coordinate activities with Engineering, Operations, Quality, Automation, and external vendors to ensure project milestones are achieved.
Documentation & GMP Compliance
* Prepare, review, and maintain project documentation including
URS, functional/design specifications, commissioning plans, test scripts, and handover packages
.
* Ensure project activities are executed in accordance with
GMP, FDA, and internal quality standards
, supporting audit and inspection readiness.
* Participate in
risk assessments
, impact assessments, and change control activities throughout the project lifecycle.
Commissioning, Start-Up & Troubleshooting
* Actively support
commissioning and qualification activities
for clean utilities, process support systems, and equipment.
* Execute commissioning test scripts, document results, and support system start-up activities.
* Assist in troubleshooting issues encountered during commissioning, qualification, or early operational phases, working closely with vendors and site SMEs.
* Support deviation resolution, punch-list closeout, and transition to operations.
Experience & Qualifications
* 3–5 years' engineering experience within a
GMP-regulated pharmaceutical or life sciences environment
.
* Hands-on experience supporting
clean utilities, facilities, or process support systems
(e.g. WFI, PW, Clean Steam, HVAC, CIP).
* Working knowledge of project lifecycle phases including requirements definition, design, installation, commissioning, and handover.
* Experience preparing and maintaining technical and GMP documentation such as
URS, test plans, commissioning reports, and as-built documentation
.
* Exposure to validation, qualification, and investigation processes is highly advantageous.
Skills & Competencies
* Strong organisational skills with the ability to manage multiple workstreams and priorities.
* Practical, hands-on approach to problem solving, particularly during commissioning and start-up phases.
* Sound understanding of
GMP and FDA regulatory requirements
as they apply to utilities and manufacturing systems.
* Effective communicator, capable of working cross-functionally with Engineering, Manufacturing, Quality, and external contractors.
* High attention to detail, with a strong focus on safety, quality, and compliance.
* Ability to work independently while contributing effectively within a project team.
Desirable Qualifications
* Degree in Mechanical, Electrical, Process, Chemical, or related engineering discipline.
* Experience working on
clean utility or aseptic manufacturing projects