Validation Engineer Job at Katalyst Healthcares & Life Sciences, Carlsbad, CA

  • Katalyst Healthcares & Life Sciences
  • Carlsbad, CA

Job Description

Job-ID33218487Reference26-01969Remote50% Remote Summary : We are seeking an experienced Process Validation Engineer to lead validation strategy, execution, and documentation. The role provides technical leadership across manufacturing, development, quality, and project teams within a cGMP environment. Roles & Responsibilities : • Develop and implement process validation, qualification, and CPV strategies.

  • Generate, review, and approve validation protocols and reports.
  • Design, schedule, execute, and evaluate qualification and validation studies.
  • Lead validation investigations, impact assessments, and process control strategy development.
  • Analyze process and product data to evaluate performance and identify improvements.
  • Serve as a validation SME during audits and customer meetings.
  • Manage validation activities across cross-functional manufacturing, development, quality, and project teams.
  • Provide technical leadership and influence teams without direct authority. Education & Experience : • 7+ years of experience in a cGMP environment.
  • 5+ years of Process Validation, PPQ, and/or CPV experience.
  • FDA or regulatory-agency BLA filing experience.
  • Commercial manufacturing experience.
  • Experience managing validation activities.
  • Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or a related Life Science field.
  • Strong technical writing, communication, documentation, and organizational skills.
  • Strong critical thinking and technical problem-solving abilities.
  • 10+ years of manufacturing, process validation, PPQ, and CPV experience.
  • Hands-on experience with cell culture, upstream processing, and/or downstream purification operations.
  • Experience with cGMP document control systems and procedures.
  • Strong process and product data analysis experience.
  • Experience leading and influencing cross-functional teams without direct authority.

Job Tags

Remote work

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