Pharma Packaging Engineering Lead

Pinnaql, Inc.

Allentown (Lehigh County)

On-site

USD 110,000 - 145,000

Full time

3 days ago

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Job summary

Validation & Engineering Group, Inc. in Allentown, PA, seeks an Engineering Project Manager for packaging equipment.

You will lead planning and delivery of multiple packaging equipment and asset qualification projects at the site, overseeing scope, schedule, budget and cross‑functional coordination from initiation through installation, qualification, operational handoff, and closeout. The role requires GMP pharmaceutical engineering experience, packaging operations knowledge, and strong

Qualifications

Bachelor’s degree in engineering or science.
At least 5 years of project management, engineering, or capital project experience in a cGMP-regulated pharmaceutical manufacturing or packaging environment.
Practical knowledge of pharmaceutical packaging equipment projects and the commissioning and qualification lifecycle, including FAT, SAT, IQ, OQ, and 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.
Strong leadership, facilitation, negotiation, organizational, and written and verbal communication skills.
Ability to translate technical information into clear decisions, priorities, and status communications for technical and nontechnical stakeholders.
Proficiency with Microsoft Project or an equivalent scheduling tool, as well as Microsoft Excel, Word, PowerPoint, and Teams.
Ability to work on site in Allentown.

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.