We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Lifecycle & Periodic Review Specialist
Location: Hybrid
Position Summary We are seeking a Validation Lifecycle & Periodic Review Specialist to support our client in maintaining validated systems throughout their lifecycle. This role is responsible for 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 support the execution of assessments and reviews to ensure systems remain compliant, fit for intended use, and maintained in a validated state throughout their lifecycle.
Responsibilities - Support execution of 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.
- Gather and review maintenance, calibration, deviation, change control, CAPA, and system performance information.
- Support assessments of system changes and their impact on validation status and compliance requirements.
- Assist in evaluating 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 and communicate potential compliance risks, gaps, and improvement opportunities.
- Support regulatory inspections, audits, and client requests, as required.
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.
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
