Capital Equipment Project Lead – GMP & Validation

Norgine B.V.; Cefn Hengoed; On-site; GBP 70,000 - 110,000; Full time

Job summary

Norgine is seeking a Senior Project Engineer - Capital Equipment in Hengoed to lead complex capital projects from scope through handover. You will direct project teams, manage contractors and external resources, and safeguard budgets and timelines while ensuring GMP and validation deliverables are met to regulatory standards.

You will engage in engineering design reviews, commissioning, qualification activities and maintain governance across EHS requirements, with a proactive, collaborative

Qualifications

• Strongly preferred Engineering degree or HND/HNC.
• Delivery of validated complex manufacturing process equipment capital projects up to £10M in a regulated healthcare setting.
• Hands-on experience of equipment installation, commissioning and qualification.
• Strong technical knowledge of pharmaceutical process equipment and systems.
• Comprehensive knowledge of GAMP/ISPE validation documentation, including URS, FDS, DQ, IQ, OQ and PQ.
• Understanding of cGMP principles, EU Annex 11 and Annex 15, and relevant FDA regulatory expectations.
• Experience of safe systems of work, contractor management and financial business case development.
• Confidence using Microsoft Project, Word and Excel, with basic CAD experience such as AutoCAD LT.

Responsibilities

• Lead capital equipment projects from scope definition through design, installation, commissioning and handover.
• Lead project teams and manage contractors, external resources, vendors and suppliers.
• Manage CAPEX budgets, forecasts, project timelines and financial justification.
• Manage GMP change control and validation documentation timelines.
• Lead engineering design reviews, FAT, commissioning, SAT, IOQ and process qualification/validation activities.
• Ensure compliance with EHS and regulatory requirements (UKCA, CDM, PUWER, ATEX).
• Maintain effective project governance and communication with key stakeholders.

Skills

Project leadership

Contract management

MS Project

AutoCAD LT

GMP validation

GAMP/ISPE validation docs

Regulatory knowledge

Installation/commissioning

Education

Engineering degree or HND/HNC

Chartered Engineer status

Tools

AutoCAD LT

Job description

Norgine is seeking a Senior Project Engineer - Capital Equipment in Hengoed to lead complex capital projects from scope through handover. You will direct project teams, manage contractors and external resources, and safeguard budgets and timelines while ensuring GMP and validation deliverables are met to regulatory standards.

You will engage in engineering design reviews, commissioning, qualification activities and maintain governance across EHS requirements, with a proactive, collaborative