Validation Program Manager and Site Lead

Pinnaql, Inc.; 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 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 Validation Program Manager and Site Lead to manage an annual Quality Control and Quality Assurance Validation Maintenance Program in Juncos Puerto Rico The position will provide leadership supervision resource coordination planning compliance oversight and client governance for validation services supporting QC Laboratory and QA Incoming operations

Validation Program Manager and Site Lead

Key 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

Qualifications

• Bachelors 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

At Validation & Engineering Group people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its 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