Project Manager II

Resilience•West Chester, OH

6d•Onsite

About The Position

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. 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.

Requirements

Demonstrated ability to independently lead capital or manufacturing projects from initiation through closure and handover.
Demonstrated capability in charter and scope definition, integrated schedule development, budget ownership, and leadership of cross-functional teams.
Experience gained through progressive project management roles, project leadership assignments within an engineering, quality, or operations function, or equivalent certification paired with applied project delivery.
Demonstrated knowledge in various aspects of Pharmaceutical Operations, Manufacturing and Packaging, and Product Supply Chain.
Working knowledge of GMPs as they apply to facility, equipment, and process changes.
Demonstrated ability to manage multiple concurrent projects and competing priorities within a matrixed organization.

Nice To Haves

Bachelor's degree in Engineering, Science, Business, Supply Chain, or other related discipline.
7+ years of progressive project and program management experience, or 5+ years paired with PMP certification, in the pharmaceutical or a related GMP manufacturing environment, including direct capital project delivery.
PMP certification.
Experience with lean concepts and tools.
Direct experience managing capital projects involving equipment installation, commissioning, and qualification in a regulated manufacturing environment.
Experience with Six Sigma methodologies (Green/Black Belt) and continuous improvement programs.

Responsibilities

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.
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.
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-making and resolve issues and conflicts within and across project teams, escalating to the PMO or project sponsors when resolution requires cross-functional trade-offs.
Partner with Engineering, Quality, Supply Chain, Regulatory, and Technical Services on strategy development and project execution.
Manage vendor and contractor relationships, including RFP/RFQ development, bid evaluation, contract negotiation support, and performance management through project completion.
Apply the PMO framework, stage gate reviews, tools, and processes throughout all project phases, and serve as a champion for the PMO within the organization.
Manage project punch lists, final documentation turnover (as-builts, equipment manuals, spare parts lists, preventive maintenance plans), and formal handover of new lines to Operations and Maintenance.
Facilitate lessons-learned/post-project reviews and translate findings into PMO best practices, project metrics, and future project planning.
Share best practices and provide coaching for other Project Managers on site.
Execute work in compliance with GMPs, company policies, work instructions, and standard operating procedures (SOPs).
Support GMP documentation (e.g., protocols, reports, SOPs) generated as part of project deliverables, and support deviation and CAPA management related to project activities.
Maintain a safe work environment by following all Health and Safety policies and procedures.
Use Personal Protective Equipment (PPE) as necessary.
Comply with HSE policies and trainings.
Ensure contractor and construction safety compliance on project worksites, including permit-to-work processes (e.g., lockout/tagout, hot work, confined space entry) and adherence to Process Safety Management (PSM) requirements where applicable.