Lead Validation Program Manager & Site Lead

Pinnaql

Juncos (PR)

On-site

USD 120,000 - 180,000

Full time

14 days+
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Job summary

Validation & Engineering Group is a premier service provider supporting Pharmaceutical, Biotechnology, and Medical Device industries. The company seeks a Validation Program Manager and Site Lead in Juncos, PR to oversee the QC/QA validation program, schedule resources, and ensure compliance across equipment qualification, monitoring, and documentation.

Bilingual English/Spanish is a plus. The role emphasizes leadership, client governance, and regulatory readiness, with responsibilities spanning

Qualifications

  • Bachelor's degree or higher in Engineering, Life Sciences, Pharmaceutical Sciences, or related field.
  • Eight+ years pharmaceutical/biotech validation experience.
  • Three+ years leading validation programs or multidisciplinary teams.
  • Experience with equipment qualification, lifecycle documentation, and inspection readiness.

Responsibilities

  • Provide day-to-day leadership and management oversight for the validation team.
  • Develop and maintain the integrated validation master schedule and resource plan.
  • Coordinate periodic monitoring of laboratory equipment and facilities.
  • Support regulatory audits/inspections and regulatory submissions annually.
  • Ensure timely onboarding, training, system access, and site readiness for personnel.

Skills

Leadership
Regulatory knowledge
Project management
Quality systems
Bilingual English/Spanish
Kneat CDOCs
Smartsheet
MS Project
TrackWise
cGMP compliance

Education

Bachelor's degree in Engineering/Life Sciences/Pharmaceutical Sciences

Tools

Kneat CDOCs
Smartsheet
MS Project
TrackWise

Job description

Validation & Engineering Group is a premier service provider supporting Pharmaceutical, Biotechnology, and Medical Device industries. The company seeks a Validation Program Manager and Site Lead in Juncos, PR to oversee the QC/QA validation program, schedule resources, and ensure compliance across equipment qualification, monitoring, and documentation.

Bilingual English/Spanish is a plus. The role emphasizes leadership, client governance, and regulatory readiness, with responsibilities spanning

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