Validation Engineer
Nolato MediTech AB / Kemiingenjörsjobb / Hörby
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hela Sverige Nolato MediTech develops and manufactures polymer products and systems in close cooperation with leading customers within medical technology and pharmaceuticals. We are a world leader in injection molding of silicone and have extensive knowledge in injection molding thermoplastic medical technology products, with special competence in 2K and 3K molding. Medical Excellence is our way of exceeding our clients very high standards and expectations. By adapting the principles within Lean to good manufacturing and documentation practices (GMP & GDP), we are increasing value for our clients. Nolato MediTech has two production sites in Lomma and Hörby with cleanroom production class 8 and hygiene production according to ISO 14644-1.
Nolato MediTech is expanding and looking for an experienced Validation Engineer to our quality department.
ROLE RESPONSIBILITIES
As a validation engineer your responsibility will be divided into two areas:
• planning and executing of clean room validation and the periodic review of existing clean rooms
• equipment qualification including data integrity and software validation.
Your main responsibilities are to plan, document and lead qualifications and validation in conformance to current regulations.
Furthermore you will:
• Lead and conduct risk analysis (p-FMEA) to develop various validation tests
• Issue validation plans, protocols and reports
• Lead the URS work and qualification tests
• Conduct deviation investigations
• Lead improvements projects
As a validation engineer, you have a continuous and close contact with project managers, production, technical engineers and the purchasing department.
The position is a permanent full time employment and placed in Hörby.
You should be a non-smoker/snuff user.
BACKGROUND AND PROFILE
We expect you to have a bachelor degree or similar level in experience and have worked as a validation engineer in the pharmaceutical and / or medical device industry for at least 3 years. You should have good knowledge of:
• GAMP5/Part 11
• ISO 14644-1/ISO14644-2
• Report writing (IQ, OQ, PQ)
• Production and manufacturing processes
As a person you should be quality minded, driven, proactive, structured and analytical. You will work in a customer-oriented, international environment so you must be fluent in both English and Swedish
INFORMATION AND APPLICATION
For information about the position, please contact Arléne Dahl, Quality Director,
Arlene.dahl@nolato.com , 0768-880007.
You apply by sending your CV and cover letter to
hr.meditech@nolato.comPlease apply no later than 2018-08-03
Publiceringsdatum2018-06-29Så ansöker duSista dag att ansöka är 2018-08-03
FöretagNOLATO MEDITECH AB
KontorsadressMEDICINGATAN 4
Jobbnummer 4228606
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