QA Validation Engineer
QA Validation Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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:
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.
Whats 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 130000 outstanding minds has an unusual story to tell. Join us and contribute to our unique mission.
Employment Type
Full-Time
