QA Validation Engineer

QA Validation Engineer

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 organizational 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.

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