Cleanroom Engineer
Vor 5 Tagen
Join Exyte's Global Community of Challenge Seekers
At Exyte, we're passionate about innovation and committed to engineering excellence. As a Cleanroom Engineer, you'll contribute to the design, engineering, and delivery of facilities for high-tech industries, serving people and planet through energy-saving and sustainable engineering.
About the Role
- Responsible for handling project-specific qualification and validation activities according to current GMP regulations for HVAC-, Cleanroom-, and Clean Media-Systems.
- Prepare and review qualification and validation documents, including specifications, risk analysis, plans, and reports.
- Develop 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, and report to the CQV manager/project management.
- Work on-site to coordinate and conduct qualification independently, working under time pressure to drive projects forward.
Requirements
- 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, with good German skills.
- Proactive and independent working style, with a high level of quality awareness, efficiency, and accuracy.
What We Offer
- Onboarding event with new colleagues.
- Spacious workstations with height-adjustable desks.
- Buddy-System for familiarization with colleagues.
- Work-life balance with mobile working options.
- Catering and fitness contract subsidies.
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