Senior Validation Program Manager & Site Lead
Validation & Engineering Group
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Descripción de la vacante
Validation & Engineering Group is seeking a Validation Program Manager and Site Lead to manage an annual Quality Control and Quality Assurance Validation Maintenance Program in Juncos, Puerto Rico. You will provide leadership, supervision, resource coordination, planning, compliance oversight and client governance for validation services supporting QC Laboratory and QA Incoming operations.
The role requires a Bachelor's degree in Engineering, Life Sciences or a related discipline and 8+ years in
Formación
- Bachelor's degree in Engineering, Life Sciences, or a related discipline.
- 8+ years pharma/biotech validation experience.
- 3+ years leading validation programs or multidisciplinary technical teams.
Responsabilidades
- Lead validation team daily operations and planning.
- Maintain validation master schedule and resource plan.
- Coordinate periodic monitoring of equipment and facilities.
- Support regulatory audits and submissions annually.
- Oversee documentation via Kneat CDOCs or similar.
- Ensure training, access, and site readiness for personnel.
- Manage deviations, CAPAs, and QA events within timelines.
Conocimientos
Educación
Herramientas
Descripción del empleo
Validation & Engineering Group is seeking a Validation Program Manager and Site Lead to manage an annual Quality Control and Quality Assurance Validation Maintenance Program in Juncos, Puerto Rico. You will provide leadership, supervision, resource coordination, planning, compliance oversight and client governance for validation services supporting QC Laboratory and QA Incoming operations.
The role requires a Bachelor's degree in Engineering, Life Sciences or a related discipline and 8+ years in
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