Senior Qualification and Validation Expert

vor 1 Woche

Nürnberg, Bayern, Deutschland Exyte Vollzeit

Transform Your Career with Exyte

At Exyte, we're shaping the future of high-tech markets, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. As a Group Lead Qualification - Validation, you'll be part of a global community of challenge seekers who are ambitious and passionate about innovation.

Your Key Responsibilities

  • Lead a team of 4 to 10 employees, providing technical and disciplinary guidance.
  • Oversee project-specific qualification and validation activities in accordance with current GMP regulations.
  • Collaborate with project management, project controlling, and customers to ensure seamless project execution.
  • Develop and implement qualification and validation concepts for our customers.
  • Create test plans for DQ, IQ, OQ, and PQ qualification phases and execute and monitor tests.
  • Act as an interface between stakeholders, ensuring smooth communication.
  • Coordinate qualification activities at customer sites, working under time pressure to drive projects forward.
  • Utilize project networks for further acquisition activities.

Your Qualifications

  • Bachelor's degree in biotechnology, pharmaceutical engineering, process engineering, medical engineering, facility management & engineering, or a related field.
  • At least 4 years of experience in qualification and validation, preferably in equipment and/or process plants.
  • Proven leadership experience, including project environments.
  • Technical knowledge of current regulations, including GMP guidelines, ISO, 21 CFR, Annex 15, and data integrity.
  • Fluent German language skills, with excellent English language skills.
  • Proactive, quality-conscious, and efficient work style.

What We Offer

  • Onboarding event for new colleagues.
  • Spacious workstations with height-adjustable desks.
  • Buddy system for team familiarization.
  • Flexible work-life balance.
  • Free coffee and water dispensers.
  • Subsidized fitness contracts.

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