An exciting clinical-stage biotech company, located in the Los Angeles area, is seeking a talented professional to join a their team as a Senior Quality Engineer.
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.