QA Validation Engineer

Thermo Fisher Scientific; Swindon; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a QA Validation Engineer to join their Proactive Quality department in Swindon. The successful candidate will lead validation activities, ensure compliance with GMP standards, and support regulatory audits. This role offers competitive compensation and a range of benefits including a pension plan and private medical insurance.

Benefits

Competitive base salary

Annual bonus

Free on-site car parking

Contributory Pension

Private medical insurance

Flexible benefits

Qualifications

• Professional experience in process and cleaning validation in the pharmaceutical industries.
• Excellent interpersonal and communication skills.
• Ability to multi-task and meet tight deadlines.

Responsibilities

• Lead all aspects of sitewide process and cleaning validation activities.
• Author validation protocols and reports according to GMP.
• Coordinate manufacturing activities related to registration and validation.

Skills

Proficient knowledge of process validation

Statistical analysis

Technical writing skills

Interpersonal skills

Education

Science based degree e.g. BSc or MSc

Tools

MiniTab

Job description

Join to apply for the QA Validation Engineer role at Thermo Fisher Scientific

1 day ago Be among the first 25 applicants

Join to apply for the QA Validation Engineer role at Thermo Fisher Scientific

Get AI-powered advice on this job and more exclusive features.

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Title: QA Validation Engineer

Position Summary:

This role is available within the Proactive Quality department at Thermo Fisher Scientific, Swindon.

Lead all aspects of sitewide process and cleaning validation activities. Plan and implement process validation studies.

Responsibilities:

• Follow the technology transfer phases from the initial project kick-off to the commercial readiness, acting as a point of reference for Quality and Validation technical aspects.
• Work closely with technical and quality teams to develop a robust validation strategy.
• Author Process and Cleaning Validation protocols and reports for registration and validation batches, in accordance with GMP and corporate standards.
• Provide Qualitative and Technical recommendations to permit site operation within regulatory requirements.
• Statistically process data through computer applications (Excel/Minitab).
• Coordinate manufacturing activities related to registration and validation batches.
• Ensure that new product introduction and all process changes are adequately evaluated and managed through change control management.
• Support in preparation and participation to Clients’ and Regulatory audits with regards to validation activities.
  
  

Minimum Requirements/Qualifications:

• Science based degree e.g. BSc or MSc or equivalent experience.
• Professional experience in process and cleaning validation in the pharmaceutical industries, preferably sterile manufacturing.
• Proficient knowledge of process validation, cleaning validation and continuous process improvement.
• Knowledge of mainstream statistical software analysis programs such as MiniTab.
• Solid understanding of EU/US GMP regulations and guidelines for UK as per the ‘Orange Guide.’
• Technical writing skills - Deviations, reports, investigations, SOPs.
• Excellent interpersonal skills, communication, and organisational skills.
• Ability to multi-task, meeting tight deadlines.
  
  

What’s in it for you:

Competitive base salary, Annual bonus, Free on-site car parking, Contributory Pension, Private medical insurance and Flexible benefits.

At Thermo Fisher Scientific, each one of our 130,000 outstanding minds has an unusual story to tell. Join us and contribute to our unique mission.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Production, Supply Chain, and Manufacturing

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at Thermo Fisher Scientific by 2x

Sign in to set job alerts for “Quality Assurance Engineer” roles.

Abingdon-On-Thames, England, United Kingdom 55 minutes ago

Newbury, England, United Kingdom 1 day ago

Quality Assurance Engineer II - Technical

Witney, England, United Kingdom 1 month ago

Oxford, England, United Kingdom 1 day ago

Quality Assurance Engineer - Infrastructure

Oxford, England, United Kingdom 2 weeks ago

Swindon, England, United Kingdom 2 weeks ago

Abingdon-On-Thames, England, United Kingdom 2 days ago

Abingdon-On-Thames, England, United Kingdom 6 days ago

Lower Stanton St Quintin, England, United Kingdom 2 months ago

Melksham, England, United Kingdom 2 months ago

Senior Software Design Quality Assurance Engineer

Oxford, England, United Kingdom 1 week ago

Oxford, England, United Kingdom 3 weeks ago

Didcot, England, United Kingdom 23 minutes ago

Witney, England, United Kingdom 1 month ago

Wiltshire, England, United Kingdom 2 weeks ago

Product Assurance Manager / Quality Assurance Manager

Harwell, England, United Kingdom 19 minutes ago

Newbury, England, United Kingdom 1 week ago

Wiltshire, England, United Kingdom 1 week ago

Swindon, England, United Kingdom 3 days ago

Newbury, England, United Kingdom 5 days ago

Newbury, England, United Kingdom 1 day ago

Oxfordshire, England, United Kingdom 1 month ago

Control System Design and Simulation Team Leader

Culham, England, United Kingdom 16 hours ago

Abingdon-On-Thames, England, United Kingdom 2 weeks ago

Control System Design and Simulation Team Leader

Senior Manager, Pharmacovigilance Quality Assurance, R&D Quality and Compliance

Oxford, England, United Kingdom 1 day ago

Stroud, England, United Kingdom 3 days ago

Stroud, England, United Kingdom 3 days ago

Swindon, England, United Kingdom 2 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.