Pharmaceutical Engineering Manager

Northumbria Healthcare Nhs Foundation Trust; North East; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading NHS foundation trust is seeking a Pharmaceutical Engineering Manager for its Medicines Manufacturing Centre. You will lead engineering and maintenance for sterile manufacturing operations, ensuring compliance with MHRA and GMP standards. Ideal candidates will have an engineering degree and experience in validation, maintenance management, and leadership. This role offers a unique opportunity to shape a new NHS manufacturing facility and make a real impact on patient care.

Qualifications

• Proven leadership capabilities in a manufacturing/engineering environment.
• In-depth understanding of GMP and regulatory compliance.
• Experience in validation and lifecycle management of critical systems.

Responsibilities

• Lead engineering functions within the Medicines Manufacturing Centre.
• Ensure compliance with MHRA, GMP, GEP, HTM, ISO, and HBN standards.
• Manage maintenance and lifecycle of critical engineering systems.

Skills

Leadership

Technical knowledge of GMP

Compliance management

Project management

Education

Engineering degree

GMP qualification

Tools

HVAC systems

Building Management Systems

Isolators

Job description

Overview

A Vacancy at Northumbria Healthcare - NHCT Northumbria Healthcare NHS Foundation Trust. 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. 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. 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.

Key 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 of maintenance contracts with any service provider for specialist equipment where outsourced servicing is necessary