Thermal Validation Engineer

GlaxoSmithKline; Barnard Castle; On-site; GBP 45,000 - 60,000; Full time

Job summary

GSK is seeking a dedicated engineer to lead thermal validation for sterilisation and controlled environments at Barnard Castle. You will design, run and report validation studies for autoclaves, depyrogenation tunnels, and CIP/SIP systems, collaborating with manufacturing, quality and external contractors.

You will analyze thermometric data, prepare validation reports and support regulatory documentation. The role emphasizes problem solving, safe practices and patient impact within an on-site,

Qualifications

• Relevant technical qualification in engineering, science or validation (e.g. HNC, HND, BSc or equivalent).
• Practical experience in thermal validation, sterilisation processes or validated controlled environments.
• Knowledge of pharmaceutical regulatory expectations and GMP.
• Experience with thermometric monitoring and biological indicators testing and data analysis.
• Proven experience preparing validation protocols, reports and technical documentation.
• Role is on-site at Barnard Castle with Early and Late shift rotation.

Responsibilities

• Plan, prepare and execute thermal qualification and requalification tests for autoclaves, depyrogenation ovens, CIP/SIP and cleanrooms.
• Collect and analyse thermometric and biological indicator data and produce clear validation reports.
• Support equipment commissioning, calibration and validation documentation to meet regulatory and company standards.
• Lead root cause investigations for thermal or sterilisation deviations and implement corrective actions.
• Coordinate with cross-functional teams and external contractors to deliver validation projects on time and within scope.
• Maintain accurate validation records and support audit and inspection readiness.

Skills

Asset Life Cycle

Data Integrity

Digital Fluency

GxP Regulations

Lean Management

Manufacturing Technologies

Pharmaceutical Manufacturing

Problem Solving

Risk Awareness

Standards Compliance

Education

Technical qualification in engineering/validation (HNC/HND/BSc)

Tools

Kaye validation hardware

SAP or validation/record systems

Job description

You will lead thermal validation for sterilisation and controlled environments. You will design, run and report validation studies for autoclaves, depyrogenation tunnels, CIP/SIP and cleanroom systems. You will work closely with manufacturing, quality, validation and external contractors. We value practical problem solvers who communicate clearly, act safely and focus on patient impact. This role offers technical growth, cross-functional project experience and a chance to help GSK unite science, technology and talent to get ahead of disease together.

Responsibilities

• Plan, prepare and execute thermal qualification and requalification tests for autoclaves, depyrogenation ovens, CIP/SIP systems and controlled environments.
• Collect and analyse thermometric and biological indicator data and produce clear validation reports.
• Support equipment commissioning, calibration and validation documentation to meet regulatory and company standards.
• Lead root cause investigations for thermal or sterilisation deviations and implement corrective actions.
• Coordinate with cross-functional teams and external contractors to deliver validation projects on time and within scope.
• Maintain accurate validation records and support audit and inspection readiness.

Why You?

Basic Qualification

• Relevant technical qualification in engineering, science or validation (for example HNC, HND, BSc or equivalent experience).
• Practical experience in thermal validation, sterilisation processes or controlled environment validation.
• Knowledge of pharmaceutical regulatory expectations and good manufacturing practices.
• Experience with thermometric monitoring and biological indicator testing and basic data analysis.
• Proven experience preparing validation protocols, reports and technical documentation.
• This role is on-site at Barnard Castle on a Early and Late shift rotation.

Preferred Qualification

• Experience with Kaye or similar validation hardware and software.
• Hands-on experience with autoclave, depyrogenation tunnel or cleanroom qualification in sterile manufacturing.
• Familiarity with SAP or other validation/record management systems.
• Background in root cause analysis and continuous improvement methods.
• Experience managing contractor activities during commissioning and qualification.
• Willingness to work shift patterns when required to support validation schedules.

Skills

• Asset Life Cycle Management
• Data Integrity
• Digital Fluency
• GxP Regulations
• Lean Management
• Manufacturing Technologies
• Pharmaceutical Manufacturing
• Problem Solving
• Risk Awareness
• Standards Compliance

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.