Validation Program Manager and Site Lead (Temuco)

Validation Program Manager and Site Lead (Temuco)

22 sep
|
Validation & Engineering Group
|
Temuco

22 sep

Validation & Engineering Group

Temuco

Validation & Engineering Group Inc V⪚ 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 rout

📌 Validation Program Manager and Site Lead (Temuco)
🏢 Validation & Engineering Group
📍 Temuco

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