Senior Validation Lead

Vor 2 Tagen


Nürnberg, Bayern, Deutschland Exyte Vollzeit

About the Role

We are seeking a highly experienced and skilled Senior Validation Lead to join our team at Exyte. As a key member of our Bio Life Sciences division, you will be responsible for leading the qualification and validation activities for our pharmaceutical plants.

Key Responsibilities

  • Lead a team of 4-10 employees in qualification and validation activities
  • Develop and implement qualification and validation plans in accordance with current GMP regulations
  • Collaborate with project management and customers to ensure smooth project execution
  • Advise customers on qualification and validation concepts and implement them on-site
  • Create test plans for qualification phases DQ, IQ, OQ, and PQ
  • Act as an interface between stakeholders and ensure effective communication
  • Coordinate qualification activities on-site and drive projects forward under time pressure
  • Utilize project work for further acquisition activities

Requirements

  • Master's degree in biotechnology, pharmaceutical engineering, process engineering, medical 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 in project environments
  • Technical knowledge of current regulations for qualification and validation (GMP guidelines, ISO, 21 CFR, Annex 15, data integrity)
  • Project management experience
  • Fluent German language skills, with very good English language skills
  • Ability to work independently, efficiently, and with high quality

What We Offer

  • Two-day onboarding event for new colleagues
  • Spacious workstations with height-adjustable desks in our attractive location
  • Buddy system for close familiarization with colleagues
  • Work-life balance with mobile working options
  • Free coffee and water dispensers
  • Subsidized fitness contract through Qualitrain


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