- Senior Validation Lifecycle & Periodic Review Specialist
Location: 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
