Validation Lifecycle & Periodic Review Specialist
HybridThousand Oaks, California, United States
Job Summary
Validation Lifecycle & Periodic Review Specialist responsible for supporting validation lifecycle and periodic review activities for GMP systems, executing EQPRs, CTCPRs, CSPRs, and AATRs; gathering and reviewing maintenance, calibration, deviation, change control, CAPA, and system performance information; assessing changes and their impact on validation status; evaluating systems for continued suitability and compliance; authoring and revising periodic review reports and validation lifecycle documentation; developing and maintaining Validation Master Plans (VMPs); supporting APR activities; collaborating across Engineering, Quality, Operations, Maintenance, Automation, and Validation; identifying compliance risks and improvement opportunities; supporting regulatory inspections and client requests.
Required Qualifications
- Bachelor's degree in a technical, scientific, quality, compliance, engineering, or related discipline
- Minimum 2 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
- Experience supporting GMP systems, quality systems, validation programs, compliance activities, or related technical functions
- Experience authoring, reviewing, or supporting GMP documentation
- Understanding of validation lifecycle concepts, quality systems, and GMP compliance requirements
- Strong technical writing, organizational, and communication skills
- Ability to manage multiple assignments and priorities in a fast-paced environment
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