Department: VEG
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:
- Validation Lifecycle & Periodic Review Program Manager
Position Summary
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.
In addition to providing program leadership and client interface responsibilities, the successful candidate will be expected to actively support execution activities as needed, including review assessments, technical evaluations, report generation, and other validation lifecycle deliverables.
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.
Required Qualifications
- 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.
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
- 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.
