Project Manager, Regulatory Compliance Specialist

Engineering Project Manager (Capital Projects)

This role oversees the full life cycle of large-scale capital projects, from initial concept and design through estimating, equipment fabrication and construction, commissioning, validation, start-up, and project closeout. The Engineering Project Manager develops multi-objective project scopes, forecasts financial spending, and builds detailed schedules while ensuring compliance with all applicable codes and regulations. The position requires hands-on leadership of multi-million-dollar projects, frequent interaction with diverse stakeholders, and clear communication of project status and key deliverables throughout the project life cycle.

The role offers exposure to complex capital equipment initiatives and facility expansion projects, along with long-term project continuity and professional development opportunities.

Responsibilities:

• Lead all phases of capital project management, including design, conceptual estimating, equipment fabrication, equipment construction, commissioning, validation, start-up, and closeout.
• Develop multi-objective project scopes that balance technical, financial, schedule, and regulatory requirements.
• Create preliminary project budgets and schedules for assigned projects and maintain accurate financial forecasts throughout the project life cycle.
• Work closely with project sponsors and stakeholders to prepare Capital Project Appropriation (CPA) requests, including project descriptions, justifications, cost estimates, budgets, schedules, analysis of alternatives, and other required information.
• Research and present alternative solutions and cost options to customers while ensuring compliance with all relevant user codes and regulatory requirements.
• Prepare and deliver key project presentations and status updates to multiple stakeholders to obtain approvals to initiate projects and to provide intermediate progress updates.
• Facilitate meetings, presentations, and regular reporting to ensure stakeholders remain informed of project status, risks, and changes.
• Develop Request for Proposal (RFP) documents for design services, construction services, and major equipment purchases as appropriate.
• Develop capital and expense budget requests for future projects during the annual budget cycle.
• Arrange training for maintenance and operating personnel and ensure proper distribution of all testing, certification, validation, as-built documentation, spare parts lists, operating manuals, maintenance manuals, and drawings.
• Manage and coordinate, in collaboration with site customers and subject matter experts, the safe, timely, high-quality, cost-effective, and compliant implementation of assigned projects.
• Administer, resolve, and control all design, construction, contractual, and financial issues on assigned projects, including change management and issue escalation as needed.
• Oversee project completion by starting up and checking out new equipment and systems, inspecting construction, and developing and driving closure of all punch list items.
• Ensure frequent communication and conduct regularly scheduled meetings between the project team and other stakeholders to maintain alignment and address issues proactively.
• Verify that all applicable local, state, and federal regulatory requirements are met for assigned projects.
• Generate requests for proposals for purchased equipment and services as necessary and lead the procurement process for major project components.
• Lead the development of User Requirement Specifications (URS) for equipment and services, ensuring alignment with operational and regulatory needs.
• Procure, track, and close out project equipment and services purchases, maintaining accurate records and documentation.
• Provide or arrange for the development of complete design documentation for assigned projects.
• Prepare documentation necessary for project approvals, including technical, financial, and regulatory materials.
• Generate change control documentation as required to support project commissioning, validation, and compliance activities.
• Provide qualification documentation for assigned projects as applicable, ensuring alignment with cGMP and other regulated environment standards.
• Support projects across multiple facilities, including manufacturing and laboratory environments, and coordinate activities across capital equipment, packaging lines, boiler projects, warehousing projects, and related initiatives.

Essential

Skills:

• Bachelors degree in Engineering, preferably…