Senior Validation Program Lead & Site Leader

Pinnaql; Humacao (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

Validation & Engineering Group Inc V&EG a Pinnaql company in Juncos, Puerto Rico, seeks a Validation Program Manager and Site Lead to oversee an annual QC/QA validation program across laboratory and QA operations. You will lead the team, manage master plans, and coordinate regulatory submissions and audits.

The role requires oversight of equipment qualification, periodic monitoring, and insuring timely onboarding, training, and site access for assigned personnel, with collaboration across client

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related discipline.

Responsibilities

• Provide day-to-day leadership and management oversight for the validation team.
• Develop and maintain the integrated validation master schedule and resource loading plan.
• Coordinate periodic monitoring of laboratory autoclaves, isolators, and chambers.
• Support regulatory audits/inspections and submissions.
• Oversee validation documentation and audits readiness activities.
• Ensure onboarding, training, and site access readiness for personnel.

Skills

Leadership

Validation

Documentation

Regulatory readiness

English/Spanish bilingual

Education

Bachelor's degree in Engineering/Life Sciences/Pharma

Tools

Kneat-CDOCs

Smartsheet

MS Project

TrackWise

Job description

Validation & Engineering Group Inc V&EG a Pinnaql company in Juncos, Puerto Rico, seeks a Validation Program Manager and Site Lead to oversee an annual QC/QA validation program across laboratory and QA operations. You will lead the team, manage master plans, and coordinate regulatory submissions and audits.

The role requires oversight of equipment qualification, periodic monitoring, and insuring timely onboarding, training, and site access for assigned personnel, with collaboration across client