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Group Lead Qualification and Validation Specialist
vor 1 Monat
Exyte is a global leader in the design, development, and project execution of pharmaceutical plants for the life science industry. With a long history of innovation, our team of experts works together to build on our company's legacy and lead the way to a better world.
Job OverviewThe Group Lead Qualification and Validation Specialist will play a key role in ensuring the quality and compliance of our projects. This position requires strong leadership and technical skills to manage a team of professionals and collaborate with clients to deliver high-quality results.
Responsibilities- Lead a group of 4 to 10 employees, providing technical guidance and direction to ensure successful project outcomes.
- Develop and implement qualification and validation strategies according to current GMP regulations, ensuring compliance and quality standards are met.
- Collaborate with project management and clients to report progress, address concerns, and drive project forward.
- Provide expert advice on qualification and validation concepts, implementing them on-site during the final project phase.
- Create test plans for DQ, IQ, OQ, and PQ qualification phases, executing and monitoring tests to ensure quality and compliance.
- Serve as an interface between stakeholders, facilitating smooth communication and collaboration.
- Coordinate qualification activities at client sites, working independently under time pressure to successfully drive projects forward.
- Bachelor's degree in biotechnology, pharmaceutical engineering, process engineering, medical engineering, facility management & engineering, or a related field; or equivalent professional experience.
- A minimum of 4 years of experience in qualification and validation, ideally in equipment and/or process plant qualification.
- Proven track record of leading teams, including in project environments.
- Strong technical knowledge of current regulations, including GMP guidelines, ISO, 21 CFR, Annex 15, and data integrity.
- Experience in project management and fluent German language skills (mainly spoken in the project environment) and very good English language skills.
- A competitive salary range of $80,000 - $110,000 per year, based on location and experience.
- A comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
- Ongoing training and development opportunities to enhance your skills and career growth.
- A dynamic and supportive work environment, encouraging collaboration and teamwork.
- Flexible work arrangements, including mobile working options, to balance work-life demands.
If you are a motivated and experienced professional seeking a challenging role in a dynamic industry, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter outlining your qualifications and interest in the position.
