Engineer I, Validation

Job Description

When your part of Thermo Fisher Scientific, you’ll do exciting work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

We are a growing Validation Team, based across multiple sites in the UK, looking to bring in a new validation engineer. The role falls with the Quality function, and works alongside colleagues in other departments, including manufacturing and engineering. In Validation, every day is different, and with varied day-to-day responsibilities, there is always the opportunity to learn something new, develop your skills in this area and meet different people.

As the Validation Technician at the Perth site, you will be driving the preparation and execution of validation documentation, including User Requirements Specifications, Installation and Operational Qualification Protocol, Performance Qualification Protocols and Validation Summary Reports. We cover validation of equipment, cleaning and computer systems validation, however we provide support to the process validation team, working closely with them to produce a complete validation package.

The validation technician also provides assistance and mentorship to system owners with impact risk assessments to identify the qualification and validation requirements, carrying out validation activities on equipment before returning or handing over to the system owner, and assist in arranging external services when required.

Other responsibilities include:

• Supporting the team in production, external contractors and any fitters, as we engage them to help us complete our validation protocols;
• Maintain all documentation (electronic and hardcopy) in line with our document retention policy;
• Ensure compliance with safety, health and environment (SHE) legislation;
• Connect and communicate with all persons across the business, relaying information on our ongoing projects

To fill this role, we are looking for a candidate who has at least 1 year experience within a GMP environment, occupying roles in validation, QA or engineering. The role would suit a candidate with validation experience in a medical device ISO13485, biopharmaceutical, consumer health care, microbiology or related industry.

We are interested in talking to you if you have a knowledge of commissioning and equipment validation of autoclaves, temperature controlled storage and production lines. If you have experience with validation requirements for international markets, such as MDSAP, then we are happy to discuss this with you.

Do you excel in planning and time management? Or have problem solving skills you are proud of? Are you a good communicator across the board? Then please come forward as we would like to talk to you. We are looking to engage someone who has the ability to adapt to rapid changes in project priorities and meeting ambitious deadlines!