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Norgine

European specialty pharma focused on gastroenterology

Senior Project Engineer - Capital Equipment

Manufacturing EngineeringConfirmed live in the last 24 hours
Full-timeHengoed, UKNo salary listed

About the Job

Requirements

  • A strongly preferred Engineering degree or HND/HNC.
  • A robust track record of delivering validated complex manufacturing process equipment capital projects up to £10M within a regulated healthcare setting.
  • Hands-on experience with 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 with 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.

Responsibilities

  • 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.

Desired Qualifications

  • A 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.

About the Company

Norgine

European specialty pharma focused on gastroenterology

Norgine is a European specialty pharmaceutical company that develops, markets, and distributes prescription medicines for gastroenterology. Its products, such as MOVICOL, work as osmotic laxatives by drawing water into the stool to soften it and increase bowel movements, and are sold across Europe. The company distinguishes itself with a long, family-led history and deep GI expertise, now backed by Goldman Sachs Asset Management’s private equity arm to pursue growth through acquisitions and new product development. Its goal is to expand its GI-focused portfolio and strengthen its European market position through strategic acquisitions and new therapies.

Company size
1,001-5,000
Company stage
Acquired
Total funding
Not listed
Headquarters
Amsterdam, Netherlands
Founded
1906

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