Quality Assurance Validation Associate

Role: Quality Assurance Validation Associate responsible for reviewing and approving validation deliverables to ensure compliance with regulatory requirements, internal standards, and industry best practices. Main objectives include providing quality oversight for validation documents related to facilities, utilities, equipment, process qualification, cleaning, QC methods, and computer system validation. Core responsibilities involve evaluating validation master plans, qualification protocols, and change controls; supporting validation for manufacturing systems and addressing risk assessments; and participating in audits. Requirements: Bachelor’s in Biotechnology, Microbiology, Pharmacy, or related field; minimum 5 years of experience in pharmaceutical/biotech validation; proficiency with validation protocols, electronic document systems (e.g., Veeva, Kneat); deep knowledge of GMP/EU regulations and GxP guidelines. Preferred qualifications include extensive cross-functional team experience and advanced certifications. High-value specifics: biopharma manufacturing environment, validation of facilities and systems, GxP compliance, involvement in regulated environments, and experience supporting manufacturing validation projects. Location/Work Setup: based in Thousand Oaks, CA, with potential for in-person work in controlled environments. The role may involve working in gowning areas and around chemicals, requiring adherence to safety protocols.