Process Optimization and Validation Expert

1 week ago


Aliso Viejo, California, United States ZipRecruiter Full time

Key Responsibilities

  • Develop and optimize manufacturing and tech transfer processes for pharmaceutical products, focusing on efficiency, scalability, and quality.
  • Oversee the transfer of processes from R&D to manufacturing, ensuring smooth transitions and adherence to project timelines.
  • Support the tech transfer of manufacturing processes to Contract Manufacturing Organizations (CMOs) to ensure the production of high-quality pharmaceutical products.
  • Lead process validation activities, including the development of validation protocols, execution of validation studies, and preparation of validation reports.
  • Maintain accurate and detailed documentation of processes, changes, and validations to support regulatory submissions and internal audits.

This role requires a minimum of 8 years of experience in pharmaceutical manufacturing process engineering, with a focus on tech transfer, process optimization, and validation. The ideal candidate will have a strong understanding of process engineering principles, cGMP regulations, and regulatory requirements for pharmaceutical manufacturing.



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