Lead Engineer Qualification Specialist
Vor 6 Tagen
Unlock Your Potential as a Lead Engineer Qualification Specialist
At Exyte, we're committed to delivering exceptional results in the high-tech industry. As a Lead Engineer Qualification Specialist, you'll play a crucial role in ensuring the quality and integrity of our facilities and equipment.
About the Role
- Lead project-specific qualification and validation activities in accordance with current GMP regulations.
- Develop and review qualification and validation documents, including specifications, risk analyses, plans, and reports.
- Prepare and execute test protocols for various qualification stages (DQ, IQ, OQ, PQ).
- Coordinate with suppliers and review their documentation (FAT/SAT, technical documents).
- Communicate effectively with qualification, customer/user, technical engineers, automation, QA, and suppliers, and report to the CQV manager/project management.
- Work independently on-site to coordinate and conduct qualification activities under time pressure.
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).
- Previous 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 challenging work environment.
- Opportunities for professional growth and development.
- A competitive compensation package.
- A comprehensive benefits program.
- A collaborative and supportive team environment.
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