CQV Project Lead: Sterilization & Cleaning Validation

Veg Group

Juncos (PR)

On-site

USD 110,000 - 150,000

Full time

6 days ago

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Job summary

Validation & Engineering Group, Inc. in Puerto Rico is seeking an experienced CQV Project Manager to lead the project team supporting the Repatha P5.0 cleaning characterization and sterilization qualification program at a biologics manufacturing facility in Juncos, Puerto Rico.

The Project Manager will serve as V&E Group's primary project representative and will be responsible for staffing, schedule, cost, execution coordination, progress reporting, risk management, and overall delivery of the

Qualifications

Bachelor's degree in Engineering, Science, Project Management, or related technical discipline.
Significant experience managing CQV or validation projects in pharmaceutical or biotechnology manufacturing.
Demonstrated experience managing multidisciplinary technical teams.
Strong understanding of GMP project execution.
Experience managing project schedules, resources, costs, forecasts, and project metrics.

Responsibilities

Lead the overall Pinnaql CQV project team and serve as the primary interface with the client Project Verification Lead.
Coordinate Technical Leads and CQV resources supporting cleaning and sterilization workstreams.
Develop and maintain the detailed project execution schedule and staffing plan.
Track actual staffing and project spending against the approved plan.
Provide weekly progress reporting including cost versus plan, forecast cost to complete, and milestones.