Senior Validation Lifecycle & Periodic Review Specialis
HybridThousand Oaks, California, United States
Thousand Oaks, California, United StatesHybridFull TimeSenior LevelBachelors Degree
Full TimeSenior LevelBachelors Degree
Job Summary
Senior Validation Lifecycle & Periodic Review Specialist responsible for executing validation lifecycle activities for GMP systems including EQPRs, CTCPRs, CSPRs, and AATRs; reviewing deviations, CAPAs, and change controls; maintaining validation documentation and VMPs; supporting APR activities; collaborating with Engineering, Quality, Operations, Maintenance, Automation, and Validation personnel; providing technical guidance and mentorship to junior team members; and supporting regulatory inspections and client requests.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality, Computer Science, or a related technical discipline.
- Minimum 5 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
- Experience supporting GMP equipment, facilities, utilities, controlled temperature chambers, computerized systems, or validation programs.
- Experience authoring and reviewing GMP technical documentation.
- Strong understanding of validation lifecycle concepts, quality systems, and GMP compliance requirements.
- Strong technical writing, organizational, and communication skills.
- Ability to independently manage multiple assignments and priorities.
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