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We are now looking for a
VALIDATION ENGINEER
to strengthen our growing Design Transfer/Quality Engineering team in Espoo.
In this position you will be mainly responsible for supporting IVD product manufacturing process validations in alignment with company goals and objectives. The team is working closely with both manufacturing engineering team and quality/regulatory team. We are looking for a candidate who is genuinely interested in product quality and has initiative combined to analytical mindset. Both the senior level and less experienced candidates are encouraged to apply, as the title is not as important than the attitude.
Your key responsibilities are the following:
Qualification/validation activities for manufacturing equipment, cleaning processes, facilities, utilities, analytical methods and manufacturing processes in Espoo, Finland (occasionally in Mobidiag Paris, France) including:
- identifying validation/qualification requirements
- qualification activities (planning, protocol writing, reviewing, executing, analysing data, report writing)
- providing validation training for validation teams
- arranging and supervising third party services required for validation activities when applicable
- taking part in validation related quality management system maintenance/improvement
- taking part/facilitating/recording process risk analysis
- change control related tasks, e.g. process risk management, maintenance of change control registers
Ideally, you should have:
- Bachelor’s or Master’s degree in Biosciences, Medicine, Pharmacology, Engineering or corresponding
- experience in working in an applicable field, preferably in IVD manufacturing or quality related positions
- basic understanding of regulatory IVD requirements in Europe and US (Directive 98/79/EC, Regulation (EU) 2017/746 and 21 CFR Part 820)
- basic understanding of molecular diagnostics (e.g. microarray or qPCR) is valuable
- ability to create accurate and reliable documentation
- good written and verbal communication skills in English and preferably also in Finnish
- willingness to travel occasionally
We offer you:
– Possibility to grow and expand your expertise – working in a global growing company you will get involved in full spectrum of challenges
– Opportunities to learn continuously – we believe in investing in our employees
– Having fun – your future team members are enthusiastic, energetic and talented
Please send your CV, application and salary request by 13.2.2022 to silke.niskala@hologic.com. Use “Validation Engineer” in the subject line.
Tietoa työnantajasta
We are Mobidiag, team of roughly 200 people in Finland, driven by creating something meaningful and helping the world to be a better place by offering innovative solutions to detect infectious diseases. Mobidiag is part of Hologic Inc. - fast-growing dynamic international medical technology company. With the broad range of tests and instruments based on well-established PCR technology, Mobidiag allows fast and cost-efficient detection of most common bacteria, parasites, viruses and antibiotic resistances to answer any microbiology laboratory requirements. By using our tests patients get targeted treatment faster, more efficiently and more reliably.
We take our jobs seriously because we are doing something truly important for the world.
We cannot do it alone and we need the best people to our team! Are you one of us?
