Quality Assurance Validation Lead

1 week ago


Bedford, Massachusetts, United States Anika Full time

Job Overview:

Anika Therapeutics is in search of a Validation Operations Manager to lead the validation initiatives at the Bedford Site. This position is crucial for managing the start-up, commissioning, qualification, and revalidation efforts for diverse manufacturing processes in alignment with contemporary industry standards. The Validation Operations Manager will collaborate closely with internal departments to establish, execute, and improve the site's validation strategies.

Key Responsibilities:

  • Efficiently oversee the site validation initiatives
  • Develop and implement qualification and validation protocols
  • Facilitate the resolution of non-conformances
  • Draft and update validation master plans (VMPs)
  • Set and monitor key performance indicators
  • Assist teams involved in new product development and capital projects
  • Offer technical guidance regarding equipment upkeep
  • Identify potential risks and develop mitigation strategies
  • Contribute to the formulation and analysis of budgets
  • Lead the validation engineering team and manage external contractors

Qualifications:

  • Bachelor's degree in engineering or life sciences
  • Minimum of 5 years in validation or engineering roles
  • Proficient in qualification and validation standards
  • Strong skills in project management
  • Comprehensive understanding of quality management systems
  • Exceptional analytical and communication abilities

Preferred Skills:

  • Advanced degree or relevant post-graduate studies
  • Experience with commissioning critical utility systems
  • Familiarity with aseptic manufacturing processes
  • Knowledge of quality risk management principles
  • Expertise in validation regulations


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