The Project Engineer will support the delivery of capital and site-based projects within a highly regulated pharmaceutical manufacturing environment, with a strong focus onclean utility systems and production support infrastructure.
This role is suited to anintermediate-level engineer who has developed a solid foundation in GMP environments and is now seeking to broaden their experience acrossutilities, process support systems, and equipment projects.
Key Responsibilities Project Delivery & Coordination Support the execution of equipment, facility, andclean 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 inrisk assessments, impact assessments, and change control activities throughout the project lifecycle.
Commissioning, Start-Up & Troubleshooting Actively supportcommissioning 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 35 years engineering experience within a GMP-regulated pharmaceutical or life sciences environment.
Hands-on experience supportingclean 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 onclean utility or aseptic manufacturing projects Skills: HVAC Utilities Clean Utilities Purified Water Project Engineering Project Management CIP Systems Benefits: On Site Parking