Senior Pharma Packaging Project Leader — GMP & Qualification

Pinnaql; New Jersey; On-site; USD 120,000 - 165,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks an Engineering Project Manager for packaging equipment to lead planning, scheduling, and delivery of multiple projects across GMP pharmaceutical environments.

You will oversee scope, budgets, and cross-functional coordination from initiation to closeout, ensuring quality and regulatory compliance. The role requires hands-on experience with FAT/SAT, IQ/OQ/PQ, and validation activities, plus strong communication and leadership to drive projects with

Qualifications

• Bachelor’s degree in engineering or science.
• 5+ years of project management, engineering, or capital projects experience in a cGMP pharmaceutical manufacturing or packaging environment.
• Practical knowledge of pharmaceutical packaging equipment projects and the commissioning and qualification lifecycle (FAT, SAT, IQ, OQ, PQ).
• Demonstrated success managing scope, schedules, budgets, resources, risks, and cross-functional teams across multiple concurrent projects.
• Working knowledge of GMP requirements, change control, deviation and CAPA processes, validation documentation, and controlled project records.

Responsibilities

• Lead multiple concurrent engineering, equipment installation, and qualification projects from initiation through execution, operational handoff, and closeout.
• Define and maintain project charters, scope, deliverables, assumptions, acceptance criteria, resource plans, schedules, budgets, milestones, and governance routines.
• Develop integrated project schedules that align design, procurement, vendor activities, FAT/SAT, site preparation, installation, commissioning, IQ/OQ/PQ, training, turnover, and production readiness activities.
• Monitor cost, schedule, resource utilization, dependencies, and cost forecasts; identify variances early and drive recovery or mitigation plans.
• Coordinate Engineering, Validation, Quality, Operations, Maintenance, Automation, EHS, Procurement, contractors, and equipment vendors.
• Facilitate project kickoff, status, risk, design review, readiness, and decision-making meetings; issue concise meeting records, action logs, dashboards, and executive updates.
• Maintain project risk, issue, decision, change, and action registers; elevate critical blockers promptly and secure timely decisions from accountable stakeholders.
• Lead scope and change control, including evaluating potential cost, schedule, quality, compliance, and operational impacts before implementation.
• Ensure project plans incorporate GMP, validation, quality, safety, data integrity, documentation, and site procedural requirements.
• Support equipment and technology transfer activities, including URS development, vendor evaluation, design reviews, FAT/SAT, commissioning, qualification, and operational integration.
• Coordinate validation resources and documentation deliverables to ensure protocols, deviations, approvals, and reports are completed in the correct sequence and according to schedule.
• Balance planned work with emerging site priorities by reallocating resources and resequencing activities while protecting critical-path commitments.
• Drive project closeout, including punch-list completion, financial reconciliation, documentation turnover, lessons learned, and transition to business ownership.

Skills

Leadership

Project management

Cross-functional coordination

GMP knowledge

Communication skills

Education

Bachelor’s degree in engineering or science

Tools

Microsoft Project

Excel

Job description

Validation & Engineering Group, Inc. seeks an Engineering Project Manager for packaging equipment to lead planning, scheduling, and delivery of multiple projects across GMP pharmaceutical environments.

You will oversee scope, budgets, and cross-functional coordination from initiation to closeout, ensuring quality and regulatory compliance. The role requires hands-on experience with FAT/SAT, IQ/OQ/PQ, and validation activities, plus strong communication and leadership to drive projects with