Senior Validation Specialist

vor 4 Wochen


Nürnberg, Bayern, Deutschland Exyte Vollzeit
Unlock Your Potential as a Group Lead Qualification and Validation at Exyte

Are you a seasoned professional with a passion for validation and qualification? Do you have a strong background in biotechnology, pharmaceutical engineering, or a related field? We're seeking a highly skilled Group Lead Qualification and Validation to join our team at Exyte.

About the Role

As a Group Lead Qualification and Validation, you will be responsible for leading a team of 4-10 employees in project-specific qualification and validation activities. You will work closely with project management, project controlling, and customers to ensure seamless execution and delivery. Your expertise in GMP regulations, project management, and team leadership will be invaluable in driving our projects forward.

Key Responsibilities
  • Lead a team of 4-10 employees in project-specific qualification and validation activities
  • Develop and implement qualification and validation concepts for our customers
  • Create test plans for DQ, IQ, OQ, and PQ qualification phases
  • Act as an interface between stakeholders and ensure smooth communication
  • Coordinate qualification activities at customer sites under time pressure
  • Use project work to develop new business opportunities
Requirements
  • Master's degree in biotechnology, pharmaceutical engineering, or a related field
  • At least 4 years of experience in qualification and validation, ideally in equipment and/or process plants
  • Proven leadership experience in a project environment
  • Strong technical knowledge of GMP regulations, ISO, 21 CFR, Annex 15, and data integrity
  • Fluent German language skills, with excellent English language skills
What We Offer
  • Two-day onboarding event with new colleagues
  • Attractive location with spacious workstations and height-adjustable desks
  • Buddy-System for close familiarisation with colleagues
  • Work-life balance with mobile working options
  • Free coffee and water dispensers on every floor
  • Subsidised fitness contract through Qualitrain

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