Work Schedule
Other
Environmental Conditions
Office
Job Description
Thermo Fisher Scientific Inc. is seeking an accomplished and experienced Validation Manager to join our Process Validation team at the ImmunoDiagnostic Division in Uppsala, Sweden. As a global leader in the scientific research industry, Thermo Fisher Scientific is dedicated to helping our customers make the world healthier, cleaner, and safer.
In this role, you will have the opportunity to contribute and make a significant difference by developing and improving manufacturing processes to enhance quality, capacity, and efficiency. You will work in a stimulating environment with a high pace of investment, offering especially varied and challenging tasks.
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Responsibilities:
- Lead validation activities within project teams for new investments and production updates at our Uppsala site.
- Develop plans, strategies, test protocols, and other validation documents.
- Coordinate the implementation of validation, qualification, and commissioning until processes and equipment are released.
- Participate in User Requirement Specifications, risk analyses, and periodic reviews.
- Coordinate independent activities throughout the entire chain from initiation to handover to production.
- Drive continuous improvements.
- Cross-site participation in developing our validation processes globally.
Requirements:
- Technical or scientific university education.
- Over 10 years of experience in the medical device or pharmaceutical industry.
- Extensive experience in validation management.
- Structured way of working.
- Leadership.
- Thoroughness.
- Technical interest.
- Good oral and written proficiency in Swedish and English.
- Skilled in the application of statistical tools.
- Skilled in validation of computerized systems and GAMP5
Join us at Thermo Fisher Scientific to start your story and make a meaningful impact in people's everyday lives.