Sr. Validation Engineer II

Role: Validation Engineer overseeing equipment, system, facility, and utility qualification and validation activities within biopharma manufacturing. Objectives: ensure right first-time execution, maintain inspection readiness, and support continuous improvement. Responsibilities: lead validation activities such as Cycle Development, Design Qualification, Commissioning, Performance and Cleaning Validation; manage validation projects, track progress, report issues, and ensure timely, cost-effective implementation; serve as SME on cross-functional teams; review validation documents, support change control and re-qualification; troubleshoot validation problems; participate in audits and inspections; coordinate sample collection and data retrieval; and maintain expertise in validation standards. Qualifications: BS in engineering with 10+ years validation experience in regulated environments; proficient with systems like LIMS, MES, ERP, SCADA, DCS; strong knowledge of cGMP, validation principles, and industry guidelines; technical problem-solving skills; effective communication and collaboration skills. High-Value: extensive validation experience in biopharma manufacturing, familiarity with computerized systems, utilities, and facilities; capable of leading validation projects in a regulated, GxP environment; onsite work in Thousand Oaks, CA, with 80% site presence; may work flexible hours and shifts to support manufacturing and regulatory compliance.