Thermo Fisher Scientific
QA Validation Engineer
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Job Description
- Req#: TFSCGLOBALR01319002EXTERNALENGLOBAL
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.
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.
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob Description
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:
Minimum Requirements/Qualifications:
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.
About the company
Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.
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