Sr. Quality Engineer

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.