GMP Project Engineer for Sterile Manufacturing Facility

Mace; Leeds; Hybrid; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Career development

Hybrid working

Diverse projects

Job summary

Mace is seeking an experienced Project Engineer to support the delivery of a major sterile manufacturing facility expansion within a highly regulated GMP environment in the UK. You will provide technical leadership across design, procurement, construction, commissioning and handover, coordinating across facilities, utilities and process infrastructure.

Working within a multidisciplinary team, you will ensure engineering solutions are safe, compliant and aligned with project objectives,

Qualifications

• Degree in Mechanical, Process, Chemical, Electrical or Building Services Engineering.
• Experience in pharma/regulated environments.
• Experience delivering projects through design, construction, commissioning and handover.
• Familiarity with GMP environments and engineering quality requirements.
• Chartered Engineer status or working towards accreditation.
• Experience participating in HAZOPs and safety reviews.
• Experience working in EPCM, client-side or consultancy-led projects.

Responsibilities

• Support project governance and stage-gate processes.
• Develop URS, design specs, P&IDs, layouts and technical documentation.
• Manage technical reviews and design assurance throughout the project lifecycle.
• Coordinate engineering interfaces with design consultants, contractors, equipment vendors and site stakeholders.
• Provide technical governance for equipment procurement, installation and integration activities.
• Support construction delivery through resolution of technical queries, change control and deviations.
• Coordinate commissioning readiness activities and system boundary definitions.
• Participate in safety reviews, risk assessments and engineering assurance processes.
• Ensure engineering activities comply with project standards, quality requirements and EHS expectations.
• Support engineering delivery across facilities, utilities and building services (cleanrooms, HVAC, water, drainage, fire protection, structural works).

Education

Degree in Mechanical, Process, Chemical, Electrical or Building Services Engineering

Chartered Engineer status or working towards professional accreditation

Experience delivering projects in pharmaceutical/regulated environments

Knowledge of GMP/EU GMP/MHRA/FDA requirements

Strong stakeholder management and coordination

Experience in design, construction, commissioning and handover

Experience in HAZOPs, safety reviews and risk assessments

EPCM, client-side or consultancy-led project environments

Job description

Mace is seeking an experienced Project Engineer to support the delivery of a major sterile manufacturing facility expansion within a highly regulated GMP environment in the UK. You will provide technical leadership across design, procurement, construction, commissioning and handover, coordinating across facilities, utilities and process infrastructure.

Working within a multidisciplinary team, you will ensure engineering solutions are safe, compliant and aligned with project objectives,