Capital Project Manager

Pinnaql; Allentown (Lehigh County); On-site; USD 110,000 - 150,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Capital Project Manager to lead planning and delivery of packaging equipment and asset qualification projects at the Allentown site.

The role requires strong project management discipline, GMP packaging experience, and the ability to coordinate cross-functional teams from initiation through installation, qualification, and handoff to production. This on-site position emphasizes schedule, cost, and risk management.

Qualifications

• Bachelor’s degree in engineering or science required with 5+ years in a cGMP pharmaceutical environment.
• Experience managing scope, schedules, budgets, resources, and cross-functional teams.
• Proficiency with GMP change control, deviations, CAPA, validation documentation.
• Strong leadership and written and verbal communication skills.
• Proficiency with MS Project and MS Office suite.

Responsibilities

• Lead concurrent engineering, equipment installation, and qualification projects from initiation to closeout.
• Define project charters, scope, deliverables, and governance.
• Develop integrated schedules covering design, procurement, FAT/SAT, IQ/OQ/PQ, and training.
• Monitor cost, schedule, resources, dependencies, and forecasts; take corrective action.
• Coordinate cross-functional teams including Engineering, Validation, Quality, Operations, and Procurement.
• Facilitate meetings, document actions, dashboards, and executive updates.
• Maintain risk, issue, change, and action registers and escalate blockers.
• Lead scope and change control with cost, schedule, and quality considerations.
• Ensure GMP, validation, data integrity, and site procedures are followed.
• Support equipment transfer activities and validation documentation deliverables.
• Balance planned work with site priorities while protecting critical path.

Skills

Leadership

Communication

Project coordination

GMP knowledge

Scheduling tools

Education

Bachelor’s degree in engineering or science

PMP certification (preferred)

Tools

Microsoft Project

Excel

PowerPoint

Word

Teams

Job description

Current job opportunities are posted here as they become available.

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 ethical standards for the following position:

Capital Project Manager

Position Summary

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; 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.

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.

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.

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.