Validation Lifecycle & Periodic Review Program Manager

Pinnaql • Thousand Oaks, CA

4d

About The Position

Validation & Engineering Group (V&EG), a Pinnaql company, is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. We are seeking an experienced Validation Lifecycle & Periodic Review Program Manager to support our client in maintaining validated systems throughout their lifecycle. This role is responsible for managing validation lifecycle and periodic review programs for GMP equipment, facilities, utilities, controlled temperature chambers, computerized systems, and associated validation maintenance activities. The successful candidate will provide program leadership, client interface, and actively support execution activities such as review assessments, technical evaluations, report generation, and other validation lifecycle deliverables.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality, Computer Science, or a related technical discipline.
• Minimum 8 years of experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Minimum 3 years of experience leading validation, quality, compliance, engineering, or lifecycle management programs.
• Strong knowledge of GMP regulations and validation lifecycle principles.
• Experience managing multidisciplinary technical teams.
• Excellent written and verbal communication skills.
• Strong organizational, planning, and leadership abilities.

Nice To Haves

• Experience supporting Equipment Periodic Reviews (EQPR)
• Experience supporting Controlled Temperature Chamber Reviews (CTCPR)
• Experience supporting Computerized System Periodic Reviews (CSPR)
• Experience supporting Annual Audit Trail Reviews (AATR)
• Experience supporting Validation Master Plans (VMP)
• Experience supporting Annual Product Review (APR) support
• Experience supporting Data Integrity Assessments
• Experience supporting Change Control and Deviation Management
• Experience with Maximo, TrackWise, Kneat, CDOCS, ServiceNow, or similar systems

Responsibilities

• Serve as the primary client interface for validation lifecycle and periodic review programs.
• Develop and manage execution plans, schedules, staffing plans, and resource forecasts.
• Lead program meetings, status updates, and performance reviews.
• Monitor program metrics and key performance indicators.
• Ensure timely execution and completion of review activities and deliverables.
• Oversee the quality and consistency of validation lifecycle and periodic review documentation.
• Support development, maintenance, and periodic updates of Validation Master Plans (VMPs).
• Support Annual Product Review (APR) activities and associated summary reporting.
• Coordinate activities across equipment, facility, utility, controlled temperature chamber, and computerized system workstreams.
• Identify risks, issues, and resource constraints and develop mitigation strategies.
• Provide technical leadership and mentorship to project team members.
• Ensure compliance with GMP requirements, client procedures, and internal quality standards.
• Perform and support validation lifecycle and periodic review activities as needed to support program objectives, resource demands, and critical deliverables.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior