Project Manager

The Project Manager shall be responsible for coordinating and managing projects throughout the applicable phases of design, procurement, construction, commissioning, qualification, turnover, and closeout. The Project Manager shall ensure that assigned projects are executed in accordance with approved scope, schedule, budget, quality requirements, safety standards, and applicable regulatory and operational requirements. The Project Manager shall maintain effective communication with project stakeholders, proactively identify and mitigate project risks, and provide timely and accurate reporting on project performance. The role requires strong leadership, organizational, coordination, and problem-solving skills to support the successful delivery of multiple projects in regulated and operationally sensitive environments.

• Bachelor’s degree in engineering, Project Management, or another applicable technical discipline.
• Demonstrated experience managing capital projects in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Demonstrated experience leading projects through planning, design, procurement, construction or implementation, commissioning, qualification or validation, turnover, and financial closeout.
• Demonstrated ability to manage multiple projects concurrently.
• Experience managing external engineering firms, contractors, equipment vendors, and service providers.
• Experience managing projects within active operating or manufacturing environments.

The responsibilities listed below represent the minimum expected scope and are not intended to be all-inclusive. The Project Manager shall perform other project management, coordination, and project control activities reasonably required for the successful execution, turnover, and closeout of assigned projects, consistent with applicable project requirements, procedures, and standards.

• Establish project scope, objectives, deliverables, milestones, and execution strategy.
• Develop and maintain the project execution plan.
• Establish roles, responsibilities, and communication protocols among project stakeholders.
• Prepare project status reports and presentations for portfolio and governance reviews.
• Maintain and communicate project decisions, action items, and follow-up activities.
• Escalate significant scope, schedule, cost, safety, quality, and resource issues to management.
• Manage applicable stage-gate reviews, project approvals, and funding processes.

• Develop, review, and maintain an integrated project schedule.
• Establish engineering, procurement, construction, commissioning, qualification, and operational readiness milestones.
• Validate contractor and vendor schedules against contractual commitments and project requirements.
• Review schedule updates and challenge unsupported changes or deviations.
• Monitor critical-path activities and key project milestones.
• Identify schedule risks and develop recovery and mitigation plans.
• Coordinate shutdown activities, equipment outages, and operational constraints.
• Assess the schedule impact of proposed scope changes and change orders.
• Maintain an updated forecast for project completion.

• Manage the approved project budget.
• Maintain project commitments, actual expenditures, forecasts, and Estimate to Complete (ETC).
• Maintain project cash-flow projections.
• Review contractor and vendor invoices against actual progress and contractual requirements.
• Review and evaluate potential change orders.
• Assess cost, scope, and schedule impacts before recommending approval of changes.
• Coordinate financial information with Finance and Project Controls teams.
• Support accruals, financial forecasting, budget tracking, and project financial closeout.

• Develop technical Request for Proposal (RFP) packages and procurement documentation.
• Participate in bid clarification meetings and technical evaluations.
• Support supplier and contractor selection based on technical requirements, project needs, and established procurement processes.
• Conduct project kickoff meetings and alignment sessions with contractors, vendors, and other stakeholders.
• Coordinate contractual and commercial matters with Procurement.
• Monitor contractor and vendor performance against project scope, schedule, budget, quality expectations, and contractual obligations.
• Coordinate the resolution of procurement issues, technical discrepancies, and delivery risks.

• Coordinate User Requirements development and project scope definition.
• Manage external design firms, engineering firms, and technical consultants.
• Coordinate design reviews with relevant project stakeholders and technical disciplines.
• Track drawings, specifications, Requests for Information (RFIs), submittals, and technical decisions.
• Verify alignment with applicable engineering design standards and project requirements.
• Facilitate design reviews and constructability, operability, and maintainability assessments.
• Ensure engineering deliverables are completed, reviewed, and issued in accordance with the project schedule.
• Coordinate the resolution of design discrepancies and engineering-related issues that may affect project execution.