Validation Engineer

Katalyst Healthcares & Life Sciences
Fall River, MA
Full-time
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Responsibilities :

  • Document and execute equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes.
  • Creation of manufacturing work instructions.
  • Interface with customers on technical issues, project timeline, and validation support.
  • Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
  • Provide support for operations and communicate with Program Managers.
  • Provide training of operations personnel.
  • Depending on level of position, could lead projects of moderate scope and duration or independently perform work, which can include creating, maintaining, and communicating projects.
  • Task purpose, scope, schedule, team roles and responsibilities.
  • Plan, schedule, and conduct or coordinate detailed phases of the engineering work for projects.

Requirements :

  • Bachelor's degree in engineering required.
  • Depending on level of position 1-8 years relevant experience.
  • Strong technical writing to develop client process validations.
  • Excellent communication skills.
  • Excellent attention to detail, analytical and problem-solving skills.
  • Strong knowledge of statistics.
  • Experience with IQ, OQ and PQ protocols.
  • Knowledge of GMPs.
  • Depending on level of position - Ability to work independently, ability to initiate and manage communications with customer, ability to negotiate with clients regarding projects, timelines, and processes, develop systems to improve standard processes.
  • 2 days ago
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