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Quality Control Scientist - Physical Tester @ Northumbria Healthcare NHS Foundation Trust

Seaton Delaval, England, GBOnsiteFull-timeJob reference C9319-26-1072
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About this role

Job summary

An exciting opportunity has arisen for a proactive and passionate Physical Tester to join the Medicines Manufacturing Centre (MMC)--a cutting-edge NHS pharmaceutical production facility based in Seaton Delaval, Northumberland. The MMC is in its final design stages, with facility construction planned through. This is a fantastic opportunity to be part of a pioneering NHS manufacturing facility, supporting a leadership team committed to quality, innovation, and patient care. Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received.

All employees of the Medicine Manufacturing Centre (MMC) are currently employed by Northumbria Healthcare NHS Foundation Trust, under Agenda for Change Terms and Conditions. Should the service be transferred into alternative ownership, those employees with start dates prior to the transfer date, will be protected under Transfer of Undertakings (Protection of Employment) Regulations 2006 (TUPE). Therefore, employees will transfer to the new employer on the same terms and conditions, which are protected and the employees' continuity of employment is preserved.

Main duties of the job

  • To contribute to the delivery of a GMP compliant manufacturing facility that optimises the regional benefit from the £30 million funding provided by NHSE.
  • Support physical testing activities under the MMC's MS Licence, ensuring the compliance with MHRA and NHS standards.
  • Provides technical resource within area of expertise, advice, and support to ensure GMP compliance at the MMC.

About us

The Medicines Manufacturing Centre (MMC) is a brand-new, purpose-built NHS pharmaceutical production facility located at the Northumbria Innovation and Manufacturing Hub in Seaton Delaval, Northumberland. This cutting-edge centre is part of the North East and North Cumbria Provider Collaborative and has been established to meet the growing need for high-quality, regionally manufactured Ready-to-Administer (RtA) medicines and advanced aseptic products.

Funded with £30 million of investment from NHS England, the MMC will support a secure, sustainable supply chain for critical medicines, particularly for oncology and other high-risk therapies, while creating skilled jobs and driving innovation across the region. The facility is designed to operate under a Manufacturer's Specials Licence (MS) and aims to secure a Wholesale Dealer's Authorisation (WDA(H)), ensuring compliance with MHRA, GMP, and GDP regulations from day one.

At the MMC, quality, patient safety, and staff wellbeing are at the heart of everything we do. Our leadership team is committed to building a culture of openness, learning, and continuous improvement--offering staff a rare opportunity to help shape the systems, teams, and values of a truly modern NHS manufacturing unit.

Working at the MMC means being part of a forward-thinking and supportive team focused on enabling frontline clinical staff to spend more time with patients by delivering safe, ready-to-use medicines.

Job description

Job responsibilities

  • To be responsible for the environmental monitoring and QC equipment management (validation, Planned Preventative Maintenance (PPM), calibration, contracts etc).
  • To perform environmental testing (physical and microbiological) of the cleanroom facility consisting of four cleanroom suites and outer areas according to a regular programme and produce reports with findings.
  • To perform environmental testing of clean air devices e.g. isolator qualification.
  • To produce documentation such as Quality Control (QC) worksheets, Standard Operating Procedures (SOPs) and review data integrity compliance.
  • Contribute to core Pharmaceutical Quality Systems (PQS) such as deviations, change control impact assessments, CAPA etc where relevant to the role.
  • To understand and use the Building Management System, where appropriate.
  • To support the Senior Physical tester during technical discussions, in particular ISO and GMP standards in clean air classification.
  • Perform other testing if applicable, for example compressed air lines to support critical GMP processes.
  • To perform temperature mapping as per EU GMP for all temperature-controlled areas, including fridges, freezers, cold rooms, stability chambers, incubators and storage areas.
  • To support the QC chemistry and microbiology teams with testing workload where appropriate.
  • To role model compassionate and inclusive leadership in order to shape the creation of a collective leadership culture within the trust. This means demonstrating a consistent leadership style which
  • (a) engages, enables and empowers others
  • (b) uses coaching to promote ownership of learning and quality improvement and
  • (c) facilitates team working and collaboration within teams / departments and across organisational boundaries.

Person Specification

Qualifications / Professional Registration

Essential

  • Degree in relevant scientific discipline e.g. engineering, chemistry or equivalent experience
  • Eligible to register with a relevant professional body e.g. General Pharmaceutical Council (GPhC), Health and Care Professions Council (HCPC), Royal Society of Chemistry (RSC) or Royal Society of Biology (RSB), or Royal Pharmaceutical Society (RPS), or engineering registration or medical gas registration

Desirable

  • Qualified environmental tester
  • Qualified Medical Gas Tester
  • Professional Registration

Experience and Knowledge

Essential

  • Knowledge of GMP environmental testing requirement

Desirable

  • Experience of working in cleanroom environments
  • Experience of environmental testing in accordance with GMP and relevant ISO standards e.g. ISO14644 and EU GMP Annex 1
  • Experience of gas testing as per European Pharmacopoeia and HTM 02 01 and any other relevant medical gas legislation
  • Experience in using GMP Pharmaceutical Quality Systems e.g. SOP, worksheets, Reports, Permit to-Works, Deviations, CAPA
  • Knowledge of or experience in coaching and mentoring practices and tools
  • Knowledge of or experience in Quality improvement tools, techniques and methods

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.

Employer details

Employer name

Northumbria Healthcare NHS Foundation Trust

Address

Northumbria Healthcare Manufacturing and Innovation Hub Avenue Road Seaton Delaval NE25 0QJ

Seaton Delaval

NE25 0QJ

United Kingdom

Employer's website

https://www.northumbria.nhs.uk/ (Opens in a new tab)

Skills

HealthcareNHSPermanentFoundation Trust

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