Senior Project Engineer - Capital Equipment (Healthcare)

Norgine; Hengoed; On-site; GBP 65,000 - 90,000; Full time

Job summary

Norgine in Hengoed, United Kingdom, is seeking a Senior Project Engineer - Capital Equipment to lead complex process equipment capital projects. You will drive projects safely, on time and within budget, coordinating teams, contractors and suppliers within a regulated healthcare setting.

Main responsibilities include scope through handover, budget/forecast management, and ensuring GMP documentation and validation activities are delivered to the required standards.

Qualifications

• Engineering degree or equivalent in a relevant field.
• Proven track record delivering validated complex manufacturing capital projects up to £10M.
• Hands-on experience with installation, commissioning and qualification of equipment.
• Strong knowledge of pharmaceutical processing equipment and systems.
• Familiar with GAMP/ISPE validation documentation (URS, FDS, DQ, IQ, OQ, PQ).
• Understanding of cGMP, EU Annex 11/15, FDA expectations.

Responsibilities

• Lead capital equipment projects from scope through design, install, commissioning, qualification and handover.
• Lead project teams, manage contractors and external resources.
• Manage CAPEX budgets, forecasts and timelines.

Skills

Engineering degree

Capital equipment project delivery

GMP validation knowledge

URS/FDS/DQ/IQ/OQ/PQ docs

cGMP principles

Contractor management

MS Project

AutoCAD LT

Contract negotiation

Education

Engineering degree or HND/HNC

Tools

Microsoft Project

AutoCAD LT

Job description

Norgine in Hengoed, United Kingdom, is seeking a Senior Project Engineer - Capital Equipment to lead complex process equipment capital projects. You will drive projects safely, on time and within budget, coordinating teams, contractors and suppliers within a regulated healthcare setting.

Main responsibilities include scope through handover, budget/forecast management, and ensuring GMP documentation and validation activities are delivered to the required standards.