Job summary
An exciting opportunity has arisen for a proactive and passionate QC Senior 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 to September 2025. 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
The postholder will be responsible for leading environmental monitoring activities across cleanroom and controlled environments, ensuring compliance with GMP and ISO standards. The role includes managing testing programmes, maintaining environmental monitoring equipment, producing documentation, and leading a small team of testers. The individual will also contribute to core pharmaceutical quality systems, demonstrate inclusive leadership, and act as a technical expert in cleanroom environmental testing.
About us
We manage three major locality hospitals at North Tyneside, Wansbeck and Hexham, plus a number of smaller community hospitals and clinics from Tynemouth to Berwick on Tweed, covering one of the largest geographical areas of any NHS trust in the country. Leading in innovation and quality - opening a state of the art Northumbria Specialist Emergency Care Hospital, the first of its kind in England. Do you want to work in one of the best performing NHS organisations in England? Work in an organisation that supports its staff and focuses on staff experience as much as it does the experience of its patients? You can live and breathe in an area that has the cleanest air, cost effective living, great nightlife, some of the best schools with a wealth of history available on your doorstep. Sound too good to be true? Well it isn't, this is what you get when you work for Northumbria Healthcare, this is the Northumbria Way! Please read 'applicant guidance notes' before submitting your application.
Job description
Job responsibilities
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Manage environmental monitoring equipment, including validation, calibration, planned preventative maintenance (PPM), and service contracts.
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Conduct physical and microbiological environmental testing within cleanroom facilities and associated outer areas, following a defined schedule.
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Perform environmental testing and qualification of clean air devices, including isolators.
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Produce and maintain documentation such as Quality Control (QC) worksheets and Standard Operating Procedures (SOPs), ensuring compliance with data integrity standards.
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Support core Pharmaceutical Quality Systems (PQS) by contributing to deviation management, change control impact assessments, and Corrective and Preventive Actions (CAPA) relevant to environmental monitoring.
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Operate and interpret data from the Building Management System as applicable.
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Act as the technical adviser on physical testing, with specific expertise in ISO and GMP standards for clean air classification.
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Perform additional testing where required, such as compressed air and nitrogen gas testing.
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Conduct temperature mapping of all temperature-controlled areas (e.g. fridges, freezers, cold rooms, stability chambers, incubators, and storage spaces) in accordance with EU GMP guidelines.
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Manage the team of physical testers, ensuring training, development, and adequate contingency or capacity planning aligned with departmental needs.
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Role model compassionate and inclusive leadership, fostering a collective leadership culture that:
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Engages, enables, and empowers others.
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Uses coaching techniques to promote ownership of learning and quality improvement.
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Encourages collaboration and teamwork within and across organisational boundaries.
Job description
Job responsibilities
-
Manage environmental monitoring equipment, including validation, calibration, planned preventative maintenance (PPM), and service contracts.
-
Conduct physical and microbiological environmental testing within cleanroom facilities and associated outer areas, following a defined schedule.
-
Perform environmental testing and qualification of clean air devices, including isolators.
-
Produce and maintain documentation such as Quality Control (QC) worksheets and Standard Operating Procedures (SOPs), ensuring compliance with data integrity standards.
-
Support core Pharmaceutical Quality Systems (PQS) by contributing to deviation management, change control impact assessments, and Corrective and Preventive Actions (CAPA) relevant to environmental monitoring.
-
Operate and interpret data from the Building Management System as applicable.
-
Act as the technical adviser on physical testing, with specific expertise in ISO and GMP standards for clean air classification.
-
Perform additional testing where required, such as compressed air and nitrogen gas testing.
-
Conduct temperature mapping of all temperature-controlled areas (e.g. fridges, freezers, cold rooms, stability chambers, incubators, and storage spaces) in accordance with EU GMP guidelines.
-
Manage the team of physical testers, ensuring training, development, and adequate contingency or capacity planning aligned with departmental needs.
-
Role model compassionate and inclusive leadership, fostering a collective leadership culture that:
-
Engages, enables, and empowers others.
-
Uses coaching techniques to promote ownership of learning and quality improvement.
-
Encourages collaboration and teamwork within and across organisational boundaries.
Person Specification
Qualifications
Essential
- Degree in relevant scientific discipline e.g. engineering, chemistry or equivalent experience Or oLevel 3 or BTEC qualification preferably in Pharmaceutical Manufacture discipline or relative 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
knowledge and experience
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
- Experience in line management / team management
Person Specification
Qualifications
Essential
- Degree in relevant scientific discipline e.g. engineering, chemistry or equivalent experience Or oLevel 3 or BTEC qualification preferably in Pharmaceutical Manufacture discipline or relative 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
knowledge and experience
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
- Experience in line management / team management
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
