Senior Project Engineer - Capital Equipment

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

We have an exciting opportunity for a Senior Project Engineer - Capital Equipment to join Norgine at Hengoed. You will be part of the Project Engineering (M&S) team, reporting to the Capital Project Manager., The core responsibility of the Senior Project Engineer - Capital Equipment is to lead the delivery of complex process equipment capital projects, ensuring they are delivered safely, compliantly, on time and within budget, while achieving agreed project objectives,

• Lead capital equipment projects from scope definition through design, installation, commissioning, qualification 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, URS development and the timely delivery of GMP and validation documentation.
• Lead engineering design reviews, FAT, commissioning, SAT, IOQ and process qualification/validation activities.
• Ensure compliance with relevant EHS and regulatory requirements, including UKCA, CDM, PUWER and ATEX where applicable.
• Maintain effective project governance and communication with key stakeholders., At Norgine, you'll be part of an inclusive environment where diverse perspectives are valued. You'll have the opportunity to grow your career while making a meaningful impact on patients' lives.

Bring your curiosity, creativity and drive. However you work best, you'll find the support to succeed.

Ways of Thinking & Working to Support Your Growth

• Curious, reflective and open to different perspectives
• Collaborative across teams, functions and geographies
• Comfortable working independently and asking questions when needed

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Essential Skills and Experience

• Strongly preferred Engineering degree or HND/HNC.
• Robust track record of delivering validated complex manufacturing process equipment capital projects up to £10M within 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.
• Strong written and verbal communication skills, including experience in contract development and negotiation.

Desirable

• Formal project management qualification such as PMI PMP or PRINCE2.
• Lean or Six Sigma certification.
• Chartered Engineer status.
• Experience with risk assessment, quality assurance and risk management techniques.
• Experience supervising or mentoring colleagues.

You'll bring accountability, sound judgement and a collaborative approach, with the ability to solve problems, analyse information and take ownership of high-quality outcomes. Integrity, teamwork and continuous improvement will be important to success in this role.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine, offering a fully-rounded experience where you can make a difference, continue developing and be part of a supportive community.

Norgine: Transforming Healthcare, Backed by Over a Century of Expertise.