Validation Leader
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What you'll do
- Lead validation activities for new investments and production updates at our Uppsala site and support validation activities at other sites within the division
- Develop validation plans and strategies, test protocols, and related documentation
- Coordinate validation, qualification, and commissioning activities through to release of processes and equipment
- Participate in the development of User Requirement Specifications (URS), risk assessments, and periodic reviews
- Lead validation activities in qualification of equipment, systems, embedded software, facilities, utilities, test methods, and/or cleaning processes
- Perform laboratory analyses and participate in practical laboratory activities as part of validation work
- Take responsibility for relevant laboratory equipment, including supporting its qualification and ongoing use
- Drive continuous improvement initiatives
- Contribute to the development and harmonization of validation processes across our global sites
What they're looking for
- University degree in a relevant technical or scientific field
- At least 2–3 years of experience within the medical device or pharmaceutical industry
- Experience with leading or contributing in validation activities
- A structured and independent way of working, combined with the ability to coordinate and lead others
- Strong collaboration, communication, and problem-solving skills
- Proficiency in Swedish and English, both written and spoken
Nice to have
- Experience with statistical tools, cleaning validation, computerized system validation, or GAMP 5 is considered an advantage.
- Knowledge of German is also a plus.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Join Thermo Fisher Scientific as a Validation Leader and become part of a team developing, manufacturing, and marketing advanced blood test systems used to support the diagnosis and monitoring of allergy, asthma, and autoimmune diseases.
Based at our Uppsala site, you will work in a dynamic environment with ongoing investments, advanced technologies, and opportunities to contribute across both local and global initiatives.
How will you make an impact?
We are looking for a Validation Leader to join our global function. In this role, you will play an important part in developing and improving our manufacturing processes, helping ensure high standards of quality, capacity, and efficiency.
You will lead and coordinate validation activities related to new investments and production changes, working closely with colleagues across functions and sites to ensure that equipment, systems, and processes meet defined requirements and are ready for production.
What will you do?
- Lead validation activities for new investments and production updates at our Uppsala site and support validation activities at other sites within the division
- Develop validation plans and strategies, test protocols, and related documentation
- Coordinate validation, qualification, and commissioning activities through to release of processes and equipment
- Participate in the development of User Requirement Specifications (URS), risk assessments, and periodic reviews
- Lead validation activities in qualification of equipment, systems, embedded software, facilities, utilities, test methods, and/or cleaning processes
- Perform laboratory analyses and participate in practical laboratory activities as part of validation work
- Take responsibility for relevant laboratory equipment, including supporting its qualification and ongoing use
- Drive continuous improvement initiatives
- Contribute to the development and harmonization of validation processes across our global sites
What will you need?
- University degree in a relevant technical or scientific field
- At least 2–3 years of experience within the medical device or pharmaceutical industry
- Experience with leading or contributing in validation activities
- A structured and independent way of working, combined with the ability to coordinate and lead others
- Strong collaboration, communication, and problem-solving skills
- Proficiency in Swedish and English, both written and spoken
Experience with statistical tools, cleaning validation, computerized system validation, or GAMP 5 is considered an advantage. Knowledge of German is also a plus.
Interested?
If you are excited about combining validation expertise with hands-on work and cross-functional collaboration in an international environment, we would like to hear from you.
Apply today through our careers site and join us in enabling our customers to make the world healthier, cleaner and safer.
We review applications on an ongoing basis, so we encourage you to submit your application as soon as possible.
Company
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