Capital Equipment Project Engineer - GMP & Validation

Norgine B.V.; Cefn Hengoed; Presencial; GBP 60.000 - 80.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Capital projects

Contractor management

Budget forecasting

GMP validation

Validation docs

cGMP/FDA knowledge

Project scheduling

Contract negotiation

Communication skills

Problem solving

Educación

Engineering degree or HND/HNC

Herramientas

AutoCAD LT

MS Project

MS Excel

MS Word

Descripción del empleo

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.