Project Engineer - Capital Equipment - 12 Months FTC

Norgine B.V.; Cefn Hengoed; On-site; GBP 60,000 - 80,000; Full time

Job summary

Norgine B.V. in the United Kingdom seeks a Project Engineer - Capital Equipment to drive capital equipment projects from scope through installation, commissioning and validation within a regulated healthcare environment.

You will lead cross-functional teams, manage CAPEX and ensure timely delivery of validation documentation, while adhering to GMP, cGMP and relevant regulatory requirements. Strong technical and communication skills are essential for success.

Qualifications

• Engineering degree or HND/HNC strongly preferred.
• Experience delivering validated capital equipment projects in a regulated environment.
• Knowledge of GMP, validation concepts and regulatory expectations.

Responsibilities

• Lead capital equipment projects from scope development through installation, commissioning, qualification and handover.
• Manage project teams, contractors, vendors and suppliers.
• Manage CAPEX forecasts, expenditure, project timelines and financial justification.
• Support GMP change control, URS development and timely delivery of GMP/validation documentation.
• Lead engineering design reviews, FAT, commissioning, IQ/OQ and PQ activities.
• Ensure UKCA, CDM, PUWER and ATEX regulatory requirements are met.

Skills

Capital projects

Contractor management

Budget forecasting

GMP validation

Validation docs

cGMP/FDA knowledge

Project scheduling

Contract negotiation

Communication skills

Problem solving

Education

Engineering degree or HND/HNC

Tools

AutoCAD LT

MS Project

MS Excel

MS Word

Job description

We have an exciting opportunity for a Project Engineer - Capital Equipment to join Norgine at Hengoed. You will join the Project Engineering (M&S) team and report to the Capital Project Manager., The core responsibility of this role is to deliver assigned process equipment capital projects safely and compliantly, ensuring assets are delivered on time, within budget and in line with agreed project objectives.,

Responsibilities

• Lead capital equipment projects from scope development through installation, commissioning, qualification and handover.
• Manage project teams, contractors, vendors and suppliers.
• Manage CAPEX forecasts, expenditure, project timelines and financial justification.
• Support 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 relevant EHS and regulatory requirements are met, including UKCA, CDM, PUWER and ATEX, where applicable.
• Maintain effective project governance and communication with internal and external stakeholders., This job advert summarises the key responsibilities of the role and is not exhaustive. Norgine may adjust responsibilities to meet business and organisational needs as necessary.

Why Join Us?

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.
  Engineering degree or HND/HNC strongly preferred.
• Robust track record of delivering validated, complex manufacturing process equipment capital projects valued up to £1M within a regulated healthcare environment.
• Hands-on experience in machine installation, commissioning and qualification.
• 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.
• Confident user of Microsoft Project, Word and Excel, with basic CAD experience such as AutoCAD LT.
• Strong written and verbal communication skills, with 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.

We're looking for someone who brings accountability, sound judgement and a collaborative approach, with the confidence 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.