Senior Packaging Capital Projects Lead (GMP)

Pinnaql, Inc.; Allentown (Lehigh County); On-site; USD 90,000 - 150,000; Full time

Job summary

Validation & Engineering Group, Inc. leads a packaging site initiative in Allentown, seeking a Capital Project Manager to drive multiple equipment installation and qualification projects from initiation through closeout.

The role demands strong GMP knowledge, packaging equipment experience, and the ability to coordinate across Engineering, Validation, Quality, and Operations teams on schedule, budget, and risk management.

Qualifications

• Bachelor’s degree in engineering or science.
• At least 5 years of project management, engineering, or capital project experience in cGMP pharmaceutical manufacturing or packaging.
• Knowledge of pharmaceutical packaging equipment projects and the commissioning/qualification lifecycle (FAT/SAT/IQ/OQ/PQ).
• Experience managing scope, schedules, budgets, resources, risks, and cross-functional teams.
• Knowledge of GMP, change control, deviations, CAPA, and validated documentation.

Responsibilities

• Lead multiple concurrent engineering, equipment installation, and qualification projects from initiation through execution, 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 aligning design, procurement, vendor activities, FAT/SAT, IQ/OQ/PQ, training, turnover, and production readiness.
• Monitor cost, schedule, resource utilization, dependencies, and cost forecasts; drive recovery or mitigation plans.
• Coordinate Engineering, Validation, Quality, Operations, Maintenance, Automation, EHS, Procurement, contractors, and equipment vendors.
• Facilitate project kickoff, status, risk, design reviews, readiness, and decision meetings; issue records and dashboards.
• Maintain risk/change/decision registers; secure timely decisions.
• Lead scope and change control evaluating cost, schedule, quality, compliance, and operational impacts.
• Ensure plans reflect GMP, validation, quality, safety, data integrity, and site procedures.
• Support equipment transfer activities including URS, vendor eval, FAT/SAT, commissioning, validation, and operational integration.
• Coordinate validation resources and documentation to ensure protocols and reports are completed on schedule.
• Balance planned work with site priorities and protect critical-path commitments.
• Drive project closeout including punch lists, financial reconciliation, turnover, and lessons learned.

Skills

Project leadership

Cross-functional collaboration

Communication skills

Microsoft Project

Budget management

Problem solving

Education

Bachelor's degree in engineering or science

Tools

Microsoft Project

Excel

PowerPoint

Teams

Job description

Validation & Engineering Group, Inc. leads a packaging site initiative in Allentown, seeking a Capital Project Manager to drive multiple equipment installation and qualification projects from initiation through closeout.

The role demands strong GMP knowledge, packaging equipment experience, and the ability to coordinate across Engineering, Validation, Quality, and Operations teams on schedule, budget, and risk management.