Qualification Engineer
Vor 6 Tagen
Join Exyte's Global Community of Challenge Seekers
At Exyte, we're passionate about innovation and engineering excellence. As a Qualification Engineer - Cleanroom Expert, you'll contribute to our mission of building a better world through sustainable engineering.
About the Role
We're seeking a highly skilled and motivated individual to join our team as a Qualification Engineer - Cleanroom Expert. In this role, you'll be responsible for handling project-specific qualification and validation activities, ensuring compliance with current GMP regulations 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 supplier documentation (FAT/ SAT, technical documents)
- Communicate with qualification, customer/user, technical engineers, automation, QA, and suppliers
- Conduct on-site qualification and validation activities, 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)
- 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
- A dynamic and global community of challenge seekers
- A comprehensive onboarding program to ensure a smooth transition
- A flexible work environment with opportunities for mobile working
- A range of benefits, including fitness subsidies and catering
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