Validation Leader
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Take on the role of Validation Leader at Thermo Fisher Scientific where you will be part of a team developing producing and marketing blood test systems. These systems aid in diagnosing and tracking allergy asthma and autoimmune diseases. Positioned in Uppsala you will work in a vibrant environment with fast-paced investment and a range of demanding tasks.
How will you make an impact
We are looking for a Validation Leader to join our global function Operations Engineering & Strategy. The team consists of 9 employees with validation leaders and validation this role you will make a significant difference by developing and improving manufacturing processes to ensure flawless quality capacity and efficiency.
What will you do
Lead validation activities for new investments and production updates at our Uppsala site and support validations at other sites within the division.
Develop plans strategies test protocols and 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 from initiation to handover to production.
Drive continuous improvements.
Participate in developing our validation processes globally across sites.
Perform sampling and analytical methods in cleaning studies and cleaning validation.
What will you need
Technical or scientific university education.
Minimum of 2-3 years of experience in the medical device or pharmaceutical industry.
Experience managing validation activities.
Structured way of working with the ability to lead both people and your own work.
Experience in validation and qualification of equipment systems embedded software facilities utilities testing approaches and cleaning validation.
Proficiency in Swedish and English both oral and written; German language is a merit.
Skills in applying statistical tools are beneficial.
Experience with validation of computerized systems and GAMP5 is advantageous.
Applications are open until 11 January and well be reviewing candidates continuously throughout the process.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
