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Validation Specialist

2 months ago

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Job Title: Validation Specialist

At Diversity Nexus, we are seeking a highly skilled Validation Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring the successful implementation of various process/lab equipment at our multi-use sites.

Key Responsibilities:
  • Commission and qualify new equipment facilities, utilities, and maintain equipment systems in a qualified/validated state according to established policies and procedures.
  • Participate in projects and ongoing work activities of low to moderate complexity, with minimum supervision and given general instructions.
  • Carry out routine tasks and functions, and use basic analytical skills to recognize and solve common problems of limited scope.
  • Interact with internal customers and external service providers to achieve team goals while building trust and collaborative relationships outside the immediate organization.
Requirements:
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices.
  • Experience in the qualification of cell therapy equipment is a plus.
  • Advanced knowledge of pharmaceutical, manufacturing, and laboratory systems.
  • Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical industry.
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills with experience dealing with a diverse workforce.
  • Strong multi-tasking ability in conjunction with proven organizational skills.
Education and Experience:
  • BS in Engineering or Science-related discipline required.
  • Minimum of 5 years' experience performing/supporting activities in a GMP environment.