Thermal Validation Engineer

GSK

Fir Tree

On-site

GBP 42,000 - 62,000

Full time

3 days ago
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Job summary

GSK is seeking a validation engineer to lead thermal qualification activities for autoclaves, depyrogenation ovens, CIP/SIP and cleanroom systems at Barnard Castle. You will design, execute and report validation studies, analyze data, and ensure regulatory compliance across QA and manufacturing.

This role offers strong technical growth and cross-functional exposure with impact on patient safety. Applicants should have practical thermal validation experience and solid GMP understanding, with

Qualifications

  • Relevant technical qualification in engineering, science or validation (e.g., HNC, HND, BSc or equivalent).
  • Practical experience in thermal validation, sterilisation processes or controlled environment validation.
  • 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.
  • This role is on-site at Barnard Castle on an Early and Late shift rotation.

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.

Skills

Asset Life Cycle Management
Data Integrity
GxP Regulations
Problem Solving
Risk Awareness
Standards Compliance
Manufacturing Technologies

Education

HNC/HND/BSc or equivalent

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

We are seeking professionals with the following required skills and qualifications to help us achieve our goals

  • 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

If you have the following characteristics, it would be a plus

  • 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

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.

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