Capital Project Manager

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. (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; escape 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.