Validation Program Lead & Site Director (Puerto Rico)

Pinnaql; Barceloneta (PR); On-site; USD 110,000 - 160,000; Full time

Job summary

Validation & Engineering Group Inc V&EG, a Pinnaql company, seeks a Validation Program Manager and Site Lead in Juncos, Puerto Rico to run the annual QC and QA Validation Maintenance Program, providing leadership, overseeing resources, compliance, and client governance for validation services supporting QC, Laboratory and QA Incoming operations.

Key duties include managing the validation master schedule, coordinating periodic monitoring of autoclaves, isolators, temperature chambers, and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
• Eight or more years of pharmaceutical or biotechnology validation experience.
• At least three years leading validation programs or multidisciplinary technical teams.
• 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.

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 laboratory autoclaves and four laboratory isolators.
• Periodic reviews of temperature chambers, laminar flow hoods, inspection booths and glass washers.
• Periodic reviews of computerized systems.
• Support approximately six regulatory audits or inspections annually and four to six regulatory submissions.
• Maintain validation master plans, schedules, deliverable trackers and resource forecasts.
• Ensure onboarding, training, system access, gowning, qualifications and site access readiness for personnel.
• Establish and monitor SLAs, deliverables, priorities and escalation pathways.
• Participate in Work Center Team production scheduling and client status meetings.
• Develop and communicate monthly progress reports and KPI dashboards.
• Provide oversight of validation documentation and Kneat CDOCs workflows.
• Coordinate audit readiness activities and inspection requests.
• Support preparation/review of CMC validation content for equipment qualification, monitoring, sterilization and cleaning.
• Ensure deviations, CAPAs and safety events are addressed within timelines.
• Manage time and material reconciliation and labor model information.
• Ensure personnel availability for non-standard hours when required.

Education

Bachelor's degree in Engineering Life Sciences Pharmaceutical Sciences or a related technical discipline

Tools

Kneat CDOCs

Smartsheet

MS Project

TrackWise

Job description

Validation & Engineering Group Inc V&EG, a Pinnaql company, seeks a Validation Program Manager and Site Lead in Juncos, Puerto Rico to run the annual QC and QA Validation Maintenance Program, providing leadership, overseeing resources, compliance, and client governance for validation services supporting QC, Laboratory and QA Incoming operations.

Key duties include managing the validation master schedule, coordinating periodic monitoring of autoclaves, isolators, temperature chambers, and