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 engineers. In 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 we’ll be reviewing candidates continuously throughout the process.