Position SummaryThe Capital Project Program Manager is responsible for leading the planning, execution, and delivery of capital investment projects supporting the Barceloneta Asset Investment Plan (AIP) Program. This role provides strategic leadership for a portfolio of engineering and manufacturing improvement initiatives focused on increasing production and packaging capacity, enhancing equipment reliability, ensuring regulatory compliance, and improving operational efficiency.
Serving as the Owner's Representative, the Program Manager oversees all phases of project execution-from conceptual planning through detailed design, construction, commissioning, qualification, start-up, and project closeout. The position ensures projects are delivered safely, on schedule, within budget, and in compliance with corporate engineering standards, cGMP regulations, and applicable industry requirements.
The Program Manager collaborates closely with Operations, Engineering, Quality, Maintenance, Validation, EHS, Procurement, Finance, external engineering firms, contractors, and equipment suppliers to successfully execute capital projects that support long-term manufacturing sustainability and business continuity.
Key ResponsibilitiesProject Leadership & Capital Program Management- Lead multiple pharmaceutical capital projects from concept development through commissioning, start-up, qualification, turnover, and final closeout.
- Develop comprehensive project execution strategies, schedules, budgets, resource plans, and implementation roadmaps.
- Ensure project objectives are achieved within approved scope, budget, timeline, quality, and safety requirements.
- Apply corporate project management methodologies, stage-gate processes, engineering standards, and governance requirements.
- Define project scope and maintain alignment with approved business cases and strategic objectives.
- Manage project financial performance, including budgets, forecasts, commitments, expenditures, and cost controls.
- Monitor project schedules, identify critical path activities, and implement recovery plans when necessary.
- Lead project change management activities, including evaluation and approval of scope, schedule, and budget modifications.
Engineering & Design Management- Direct the development of conceptual, preliminary, and detailed engineering designs with Architectural & Engineering (A/E) firms.
- Review and approve engineering deliverables, technical specifications, equipment layouts, and construction documentation.
- Ensure designs incorporate constructability, operability, maintainability, safety, and lifecycle considerations.
- Support equipment selection, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), installation, commissioning, and operational turnover.
- Ensure engineering documentation accurately reflects field modifications and as-built conditions.
Construction & Contractor Management- Coordinate engineering, procurement, construction, commissioning, and qualification activities across multiple project teams.
- Manage relationships with engineering consultants, contractors, suppliers, and equipment vendors.
- Review contractor performance, project progress, invoices, claims, and contract compliance.
- Evaluate and technically review contractor and vendor change orders prior to approval.
- Ensure contractor compliance with project safety, quality, schedule, and contractual requirements.
Quality, Compliance & Validation- Ensure compliance with cGMP regulations, corporate quality systems, engineering standards, and applicable regulatory requirements.
- Coordinate Quality Assurance, Engineering, Validation, and Commissioning activities to support project execution.
- Maintain complete, accurate, and audit-ready project documentation.
- Coordinate development and approval of engineering documentation required for commissioning, qualification, and validation activities.
- Support equipment and system start-up activities while ensuring required documentation is completed and approved.
Risk Management & Project Controls- Identify, evaluate, and mitigate technical, financial, schedule, and operational project risks.
- Resolve complex project execution issues through proactive planning and stakeholder engagement.
- Escalate significant project risks and recommend appropriate mitigation strategies.
- Monitor project KPIs and performance metrics to ensure successful project execution.
Stakeholder Communication- Serve as the primary liaison between Engineering, Manufacturing, Quality, Maintenance, EHS, Procurement, Finance, PMO, contractors, and external partners.
- Prepare executive-level project reports, dashboards, forecasts, and milestone updates.
- Present project status, risks, financial performance, and strategic recommendations to Engineering Leadership and Steering Committees.
- Support capital governance reviews and management approval processes.
Project Closeout- Ensure timely project completion, financial reconciliation, documentation turnover, and lessons learned.
- Coordinate with Global Facilities Engineering (GFE) and Site Engineering to ensure:
- Equipment information is transferred into preventive maintenance systems.
- Engineering documentation is updated to reflect final as-built conditions.
- Project documentation is archived according to corporate requirements.
Minimum QualificationsEducation- Bachelor's Degree in Engineering (Mechanical, Chemical, Electrical, Industrial, Civil, or related discipline).
Experience- Minimum of fifteen (15) years of progressively responsible experience managing pharmaceutical or biotechnology capital projects.
- Demonstrated experience leading multidisciplinary engineering projects through design, construction, commissioning, qualification, and operational startup.
- Strong knowledge of pharmaceutical manufacturing facilities, packaging operations, utilities, process equipment, and GMP environments.
- Experience managing external engineering firms, contractors, equipment vendors, and construction activities.
- Proven expertise in project scheduling, cost control, risk management, procurement, contract administration, and change management.
Technical Knowledge- Thorough understanding of cGMP, FDA regulations, ISPE guidelines, pharmaceutical engineering practices, and project lifecycle management.
- Experience with commissioning, qualification, validation, and engineering documentation requirements.
- Proficiency with project management tools such as Microsoft Project, Primavera P6, or equivalent project scheduling software.
- Strong financial acumen in capital budgeting, forecasting, and project cost management.
Additional Requirements- Fully bilingual (English and Spanish), both written and verbal.
- Ability to travel up to 15% domestically and internationally.
- Professional Engineer (PE) License in Puerto Rico is preferred.
