Sr. Quality Engineer

  • 125000 USD - 125000 USD
  • West Hills, United States
  • Permanent

A distinguished clinical-stage biotech company in Los Angeles, dedicated to advancing therapies for cancer and autoimmune diseases, is in search of a talented Senior Quality Engineer to join their team.

Key Responsibilities:

  • Ensure continuous validation of Equipment, Facilities, Utilities, and Computer Systems.
  • Spearhead validation initiatives to accommodate new equipment and systems in alignment with site expansion and lifecycle demands.
  • Oversee and conduct thorough reviews and approve CQV and system lifecycle documents, ensuring compliance with protocols.
  • Maintain quality control over validation and qualification procedures, addressing deviations, CAPAs, and change controls.
  • Support vendor qualifications, regulatory inspections, and audits
  • Collaborate within cross-functional teams to commission manufacturing, warehousing, and QC testing facilities and equipment.
  • Support quality assurance activities, including Operational Excellence initiatives and management reviews, as required.

Basic Requirements:

  • Bachelor of Science with 3 years of experience min
  • Familiarity with industry standards and regulatory guidelines from FDA, EMA, and ICH.
  • Proficiency in GMP and quality management systems.
  • Experience in Facility Design and Improvement, along with associated validation requirements.
  • Demonstrated expertise in validating temperature-controlled units and conducting smoke studies.
  • Ability to operate in controlled & classified cleanroom environments.
If you are interested or would like to refer someone for the position, please reach out to OR call (619) 758-3555.
Sean Farrell Division Director

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