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Senior Quality/Validation Engineer
3 months ago
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.
