Capital Project Manager The
Capital Project Manager will lead the planning and delivery of multiple packaging equipment and asset qualification projects at the site. The role is responsible for project scope, schedule, budget, risks, priorities, and cross-functional coordination from initiation through installation, qualification, operational handoff, and closeout. The successful candidate will combine disciplined project management with practical experience in GMP pharmaceutical engineering, packaging operations, and equipment qualification.
Key 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; escalate 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.
Required 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 and remain actively engaged with site teams and project execution.
Preferred Experience - Project leadership involving automated primary and secondary packaging equipment.
- Management of CAPEX projects involving vendor selection, equipment specifications, site readiness, construction or utilities, automation, commissioning, validation, and production startup.
- Experience supporting clinical and commercial packaging operations, client-facing programs, or technology transfer initiatives.
- PMP certification or equivalent formal project management training.
- Familiarity with Lean, Six Sigma, structured problem-solving, and continuous improvement methods.
- Client-focused, collaborative leadership style with the ability to influence without direct authority.
