Project Manager II

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made . We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The Project Manager II leads and manages projects that support the West Chester and/or Blue Ash sites and is responsible for all phases of a project including project Initiation, Planning, Monitoring and Controlling, Execution, and Closure. Project responsibilities also include project team management, stakeholder management, project communications, cost tracking and forecasting spend. The scope of work includes projects or programs related to increasing site production, new manufacturing lines, utility upgrades, automation, and transformation initiatives. This role also owns capital project delivery for new and modified manufacturing and packaging lines - from conceptual design and business case development through detailed engineering, procurement, construction, commissioning, qualification, and handover to Operations, ensuring GMP compliance, safety, cost, and schedule commitments are met. Job Responsibilities Project Leadership & Planning - Lead, direct, and manage cross-functional project teams, including oversight of assigned project coordinators, contract project managers, and consultants, in support of business and operations strategies and transformation initiatives, asset commercial readiness, and critical site projects. - Develop the project charter, scope, resource requirements, and budget; build and maintain the integrated project schedule (e.g., MS Project/Primavera) and manage critical path activities. - Prepare capital/purchase requests, and cost estimates, and track actuals against budget, including forecasting, variance analysis, and recommending accruals for finance. Execution, Commissioning & Qualification - Manage supplier activities during design, fabrication, installation, commissioning, and qualification. - Manage the development of User Requirement Specifications (URS), Functional/Design Specifications (FS/DS), and coordinate Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new process/packaging equipment. - Coordinate the Installation, Operational, and Performance Qualification (IQ/OQ/PQ) and Process Performance Qualification (PPQ) activities to achieve line/equipment release for GMP production. - Coordinate equipment and process technology transfer activities, including cleaning validation, process characterization, and ramp-up/line trials to demonstrate sustained process capability. - Coordinate with Automation/Controls Engineering on integration of control systems (e.g., PLC, SCADA). - Make sure construction partner activities for facility and utility tie-ins required for line installation (e.g., WFI, clean steam, compressed air, HVAC/environmental classification) are completed on schedule. - Ensure project activities are executed through the quality change control system, including impact assessment and approval prior to implementation. Reporting, Risk & Stakeholder Management Provide regular project status reporting, including scope, schedule, cost, risk, and quality metrics (dashboards/KPIs). Develop and execute the project communication plan, including sponsor and steering committee cadence, cross-site stakeholder alignment, and escalation of decisions requiring sponsor input. Develop and maintain a project risk register, implement mitigation plans, and track residual risk through project closure. Facilitate decision-