Pharmaceutical Engineering Manager

Northumbria Healthcare NHS Foundation Trust; Seaton Delaval; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading NHS manufacturing organization in Seaton Delaval is seeking a Pharmaceutical Engineering Manager to provide leadership in a state-of-the-art facility. The role involves ensuring compliance with GMP standards, managing critical engineering systems, and contributing to continuous improvement initiatives. Ideal candidates will possess a relevant post-graduate qualification and substantial experience in a GMP-regulated environment.

Qualifications

• Substantial post-qualification experience in a GMP-regulated environment.
• Demonstrable experience in GEP and GMP-compliant maintenance.
• Strong understanding of qualification phases in manufacturing.

Responsibilities

• Provide senior engineering leadership within the Medicines Manufacturing Centre.
• Lead maintenance and lifecycle management of critical systems.
• Ensure engineering infrastructure remains validated and compliant.

Skills

Leadership

GMP compliance

Technical engineering

Lifecycle management

Project management

Education

Post-graduate qualification in Pharmaceutical Manufacturing

HNC/HND or Degree in Mechanical, Electrical, Building Services or Pharmaceutical Engineering

Tools

BMS

CAFM

Job description

Go back Northumbria Healthcare NHS Foundation Trust

Pharmaceutical Engineering Manager

The closing date is 03 December 2025

An exceptional opportunity has arisen to take a pivotal leadership role within the Medicines Manufacturing Centre (MMC) -- a state-of-the-art NHS manufacturing facility dedicated to producing sterile injectable medicinal products. Located in Seaton Delaval, Northumberland, the MMC operates under MHRA Good Manufacturing Practice (GMP) standards, ensuring a secure and resilient supply chain for Systemic Anti‑Cancer Therapy (SACT) products for the next decade.

As Pharmaceutical Engineering Manager, you will lead all engineering, maintenance, and technical support functions within the facility, ensuring equipment and utilities are designed, operated, and maintained in full compliance with GMP, safety, and environmental standards. You will be responsible for the ongoing reliability and qualification of critical systems -- including isolators, HVAC, and cleanroom infrastructure -- supporting uninterrupted sterile manufacturing operations.

Working closely with the Head of Production, Head of Quality, and wider Senior Management Team, you will play a key role in driving technical excellence, process reliability, and continuous improvement across all areas of the site. You will also contribute to facility commissioning, qualification, and validation activities, ensuring engineering readiness from initial start‑up through to sustained routine operation.

This is a unique opportunity to shape the engineering strategy of one of the NHS's flagship aseptic manufacturing facilities.

Main duties of the job

To provide senior engineering leadership within the GMP‑compliant Medicines Manufacturing Centre (MMC), ensuring all pharmaceutical manufacturing systems, utilities, and environments operate safely, efficiently, and in compliance with MHRA, GMP, GEP, HTM, HBN, and ISO standards.

To be accountable to the Head of Development and Innovation for the maintenance, reliability, and continuous improvement of the MMC's engineering infrastructure, supporting sterile manufacturing operations and future capacity development.

To lead the maintenance, qualification, and lifecycle management of critical systems including but not limited to Heating, Ventilation and Air Conditioning (HVAC), Building Management Systems (BMS), Vapourised Hydrogen Peroxide (VHP) isolators, cleanroom services, purified water systems, and semi‑automated filling equipment.

To act as the key MMC liaison with Northumbria Healthcare Facilities Management (NHFM) and external service providers for planned preventative maintenance (PPM), reactive works, statutory testing, and capital project delivery.

To ensure all engineering systems and facilities remain in a validated and compliant state, maintaining accurate records, supporting audits, and ensuring readiness for MHRA inspection.

About us

The MMC is in its final design stages, with facility construction planned to be complete very soon. Initially, staff will be employed by Northumbria Healthcare Foundation NHS Trust, with employment transferring to the Medicines Manufacturing Centre Legal Liability Partnership (LLP) upon its formation under TUPE regulations.

This is a unique opportunity to be part of a brand‑new NHS manufacturing facility, helping to shape its future from day one. If you're passionate about leadership, operational excellence, and making a real impact on patient care, we'd love to hear from you.

Job responsibilities

• To provide technical engineering leadership within the GMP‑compliant Medicines Manufacturing Centre, ensuring pharmaceutical manufacturing systems and environments meet relevant MHRA, GMP, GEP, HTM, ISO and HBN standards.
• To lead on the engineering maintenance, validation and lifecycle management of critical systems including but not limited to state‑of‑the‑art air handling units (with direct‑drive fan walls), Vapourised Hydrogen Peroxide (VHP) isolators, and semi‑automated peristaltic filling equipment.
• To act as the key MMC liaison with Northumbria Healthcare Facilities Management (NHFM) for planned preventative maintenance (PPM), reactive response, and capital project support.
• To be responsible for ensuring the engineering infrastructure within the MMC remains in a validated state and compliant with all legislative and regulatory standards.
• To act as technical advisor on pharmaceutical estates design, asset management, and future capacity planning.
• Line management and training of an Engineering Supervisor
• Management maintenance contracts with any service provider for specialist equipment where outsourced servicing is necessary

Person Specification

Qualifications

• Post‑graduate qualification in Pharmaceutical Manufacturing
• HNC/HND or Degree in Mechanical, Electrical, Building Services or Pharmaceutical Engineering or equivalent relevant experience
• Eligibility for registration with a relevant professional or regulatory body appropriate to the role

Experience

• Substantial post‑qualification experience to masters level equivalent working in a GMP‑regulated pharmaceutical manufacturing environment, ideally aseptic production or sterile fill‑finish
• Demonstrable experience in GEP and GMP‑compliant calibration, validation and planned preventative maintenance (PPM) of pharmaceutical assets
• Strong understanding of commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) phases
• Skilled in using BMS, CAFM, or asset management systems to oversee performance, reliability, and compliance
• Evidence of continuing education/professional CPD

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Address

Northumbria Manufacturing and Innovation Hub

Northumbria Healthcare NHS Foundation Trust