Job Description

Validation & Engineering Group, Inc. (V&EG) 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 talented, dedicated individual committed to work under the highest ethics standards for the following position:

• CQV Project Manager

Job Summary:

We are 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 Pinnaql's primary project representative and will be responsible for staffing, schedule, cost, execution coordination, progress reporting, risk management, and overall delivery of the contracted CQV scope.

Key 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
• Document preparation plan versus actual
• Execution plan versus actual
• Key risks and recovery actions
• Monitor protocol development, execution, reporting, and approval milestones.
• Coordinate workload and resource assignments to meet project priorities.
• Manage staffing requirements for critical 7-day/24-hour execution periods.
• Facilitate coordination meetings with Manufacturing, Engineering, Quality, QC, EHS, and other stakeholders as required.
• Ensure meeting minutes and action items are documented and tracked.
• Identify schedule, resource, cost, and execution risks.
• Develop mitigation and remediation plans when delays or cost overruns are predicted.
• Ensure project documentation and reports progress through the required review and approval process.
• Maintain team continuity and manage contractor performance.
• Ensure project execution complies with client GMP, safety, and administrative requirements.

Required 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.
• Proven experience successfully delivering projects of similar complexity and scale.
• Strong communication, leadership, and client-management skills.

Preferred Qualifications

• Experience managing cleaning validation and/or sterilization qualification programs.
• Biologics drug-substance manufacturing experience.
• Previous Amgen project experience.
• Experience with Smartsheet or similar project-management platforms.
• Familiarity with Kneat, LIMS, OSI PI, MAXIMO, and client LMS systems.

Schedule

Overall project support is anticipated from approximately October 2026 through May 2027, with significant execution activity between December 2026 and March 2027.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.