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Job Description
Senior Validation Lifecycle & Periodic Review Specialis Validation & Engineering Group, Inc Thousand Oaks, CA Job Details Full-time 1 day ago Qualifications 5 years Engineering Senior level Communication skills Full Job Description Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Hybrid Position Summary We are seeking an experienced Senior Validation Lifecycle & Periodic Review Specialist to support our client in maintaining validated systems throughout their lifecycle. This role is responsible for executing and supporting validation lifecycle and periodic review activities for GMP equipment, facilities, utilities, controlled temperature chambers, computerized systems, and associated validation maintenance activities. The successful candidate will independently perform complex assessments and reviews to ensure systems remain compliant, fit for intended use, and maintained in a validated state throughout their lifecycle. Responsibilities Execute validation lifecycle and periodic review activities for GMP systems. Perform Equipment Periodic Reviews (EQPRs), Controlled Temperature Chamber Reviews (CTCPRs), Computerized System Periodic Reviews (CSPRs), and Annual Audit Trail Reviews (AATRs), as applicable. Review and assess deviations, investigations, CAPAs, change controls, maintenance records, calibration records, and system performance data. Evaluate the impact of system changes on validation status and compliance requirements. Assess systems for continued suitability, compliance, and validated state. Author and revise periodic review reports and associated validation lifecycle documentation. Support development, maintenance, and updates of Validation Master Plans (VMPs). Support Annual Product Review (APR) activities and summary reports. Participate in cross-functional discussions with Engineering, Quality, Operations, Maintenance, Automation, and Validation personnel. Identify compliance risks, gaps, and improvement opportunities. Provide technical guidance and mentorship to junior team members, as needed. Support regulatory inspections, audits, and client requests, as required. 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. Preferred Qualifications Experience supporting one or more of the following: Equipment Periodic Reviews (EQPR) Controlled Temperature Chamber Reviews (CTCPR) Computerized System Periodic Reviews (CSPR) Annual Audit Trail Reviews (AATR) Validation Master Plans (VMP) Annual Product Review (APR) support Data Integrity Assessments Change Control and Deviation Management Validation Maintenance Programs Maximo, TrackWise, Kneat, CDOCS, ServiceNow, or similar systems At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team. Excited to build something meaningful together? We look forward to hearing from you. Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
