Cleanroom Technology Engineer
vor 3 Wochen
Exyte Central Europe GmbH is seeking a highly skilled Cleanroom Technology Engineer to join our team. As a key member of our Bio Life Sciences sector, you will be responsible for handling project-specific qualification and validation activities for HVAC-, Cleanroom- & Clean Media-Systems.
Key Responsibilities- Prepare and review qualification & validation documents (specifications, risk analysis, plans and reports)
- Prepare test protocols for different qualification stages (DQ, IQ, OQ, PQ) and execute them
- Coordinate with suppliers and review their documentation (FAT/ SAT, technical documents)
- Communicate with qualification, customer/user, technical engineers, automation, QA, and suppliers
- Conduct on-site qualification independently and work under time pressure to drive projects forward
- Completed studies in biotechnology, pharmaceutical or process engineering, medical devices or a related field
- Relevant technical knowledge of current regulations in qualification and validation (GMP, ISO, 21 CFR, Annex 15, data integrity, ISO14644)
- First-hand experience in qualification/validation, ideally in the life sciences industry
- Fluent written and oral communication skills in English and good German skills
- Proactive and independent working style with high quality awareness, efficiency and accuracy
- Onboarding event for new colleagues
- Spacious workstations with height-adjustable desks
- Buddy-System for familiarisation with colleagues
- Work-life balance with mobile working possibilities
- Catering and fitness contract subsidies
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