Note: The job is a remote job and is open to candidates in USA. Pinnaql, through Validation & Engineering Group, provides validation and engineering services to pharmaceutical, biotechnology, chemical, food, and medical device industries. The Validation Program Manager and Site Lead will manage the annual validation maintenance program in Juncos, Puerto Rico, providing leadership, resource coordination, planning, compliance oversight, and client governance for QC Laboratory and QA Incoming operations.
Responsibilities
- Provide day-to-day leadership and management oversight for the assigned validation team
- Develop and maintain the integrated validation master schedule and resource-loading plan
- Coordinate execution of: Periodic monitoring of three laboratory autoclaves and four laboratory isolators. Periodic reviews of 38 controlled-temperature chambers, 14 ISO 5 laminar-flow hoods, nine inspection booths, and two glass washers. Periodic reviews of 42 computerized systems. Approximately six regulatory audits or inspections annually. Approximately four to six regulatory submissions annually
- Maintain validation master plans, schedules, deliverable trackers, and resource forecasts
- Ensure timely onboarding, training, system access, gowning qualifications, and site-access readiness for all assigned personnel
- Establish and monitor service-level agreements, deliverables, priorities, and escalation pathways
- Participate in Work Center Team, production scheduling, NPI, project, governance, and client-status meetings
- Develop and communicate monthly progress reports, KPI dashboards, schedule adherence, success rates, failed or invalid runs, training compliance, quality events, and team efficiencies
- Provide oversight of validation documentation generated and routed through Kneat, CDOCs, or other systems
- Coordinate audit-readiness activities, anticipated inspection requests, inspection requests, pressure-test preparation, and four-block presentations
- Support preparation and review of CMC validation content associated with equipment qualification, periodic monitoring, sterilization, and cleaning validation
- Ensure deviations, discrepancies, CAPAs, and quality or safety events associated with supplier execution are addressed within established timelines
- Manage time-and-material reconciliation, earned-value reporting, and labor-model information
- Ensure personnel availability for evening, night, weekend, or holiday execution when required
Skills
- Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline
- Eight or more years of pharmaceutical or biotechnology validation experience
- At least three years leading validation programs or multidisciplinary technical teams
- Demonstrated experience with equipment qualification, periodic review, periodic monitoring, validation lifecycle documentation, and inspection readiness
- Experience supporting FDA or other regulatory inspections in a cGMP environment
- Strong working knowledge of Kneat, CDOCs, Smartsheet, MS Project, TrackWise, or equivalent systems
- Excellent technical writing, client communication, scheduling, and team-management capabilities
- Ability to communicate professionally in English and Spanish
Company Overview