Process Validation Specialist

2 weeks ago


Durham, North Carolina, United States Katalyst Healthcares and Life Sciences Full time
Job Title: Process Validation Specialist

Katalyst Healthcares and Life Sciences is seeking a highly skilled Process Validation Specialist to join our team. As a key member of our manufacturing team, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.

Key Responsibilities:
  • Develop and implement validation strategies for manufacturing processes, equipment, and cleaning procedures.
  • Create and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
  • Conduct risk assessments and develop risk mitigation strategies for manufacturing processes.
  • Maintain accurate and comprehensive validation documentation.
  • Ensure compliance with cGMP regulations and FDA guidelines.
  • Collaborate with cross-functional teams to drive process improvements and resolve issues.
Requirements:
  • Bachelor's degree in chemical engineering, pharmaceutical sciences, or a related field.
  • Proven experience in pharmaceutical process validation.
  • Strong knowledge of cGMP regulations and FDA guidelines.
  • Excellent problem-solving and analytical skills.
  • Proficiency in validation software and statistical analysis tools.
  • Effective communication and teamwork skills.

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