GMP Process Specialist

2 days ago


Riverside, California, United States NavitsPartners Full time
Job Title: GMP Process Specialist

NavitsPartners is seeking a highly skilled GMP Process Specialist to join our team. As a key member of our operations team, you will be responsible for ensuring the highest level of quality and compliance in our manufacturing processes.

Key Responsibilities:
  • Create and manage GMP training materials and resources to ensure compliance with regulatory requirements.
  • Manage the front half of the manufacturing process, including process oversight and on-call support.
  • Provide training and support to new engineers to ensure a smooth transition into their roles.
  • Assist in the management of the factory's water systems process to ensure optimal performance.
  • Lead large projects, including updating vessel diagrams, revising process rosters, and renaming equipment.
Requirements:
  • BS in Chemical, Biochemical, or Mechanical Engineering. Master's degree candidates will also be considered.
  • Pharmaceutical industry experience preferred, especially with knowledge of cGMPs, chemical reaction, and purification unit operations.
  • Knowledge of engineering documentation required for cGMP process equipment, including document revision/creation, operator training, incident investigation, hazard reviews, and data collection/analysis.
  • Experience with Corrective and Preventative Actions (CAPA) is helpful.
What We Offer:

NavitsPartners offers a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.



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