Manager, Engineering (Fixed-Term Contract 12-Month)

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 As a key member of the FME leadership team, the Manager, Engineering leads a team of engineers to deliver technical, project, and compliance engineering support across the site. The role spans capital project delivery, GMP systems support, regulatory compliance, and operational engineering — partnering closely with Manufacturing, Quality, and Maintenance to ensure the site remains in a continuous state of engineering readiness and GMP compliance. This role has a primary focus on process technical support, GMP systems reliability, and capital project delivery.

Leadership & Team Management Lead a team of engineers to deliver engineering support across capital projects, GMP systems, and compliance activities; establish clear priorities, manage workload and resources, and foster a high-performance team culture with defined development paths. Manage and oversee CapEx and operational budget requirements within area of responsibility; provide input to headcount planning and resource forecasting. Provide regular updates to FME senior leadership and project steering committees on project status, risks and mitigation plans, compliance posture, and team performance. Technical & Process Engineering Support Direct process engineering activities to resolve critical facility and equipment issues and provide ongoing technical support to manufacturing operations following project handover, partnering with Maintenance to integrate engineering support into daily operations and ensure uninterrupted GMP operations. Troubleshoot, optimize, and drive continuous improvement of major GMP process systems including PW, WFI, compressed air, nitrogen, CIP, clean steam, SCADA, Historian, and related systems. Commissioning, Qualification & Validation Support the production of engineering start-up batches and cGMP-compliant registration batches, ensuring regulatory readiness for product licensure. Lead feasibility, design, and detailed engineering for capital projects; manage renovation, construction, commissioning, qualification, and start-up of new and existing facilities, equipment, and processes. Compliance & Continuous Improvement Oversee engineering compliance activities including deviation investigations, CAPAs, and change control; ensure timely closure and systemic resolution of recurring issues. Oversee engineering documentation, drawing management, and SOP review, maintaining records in a state of audit readiness; support regulatory inspections and internal and external audits as the FME engineering subject matter expert, including inspection readiness activities and responses to observations. Project Management & Cross-Functional Coordination Manage project scope, schedule, and budget for assigned capital projects, including risk identification and mitigation planning. Select, negotiate, and manage vendors, contractors, and consultants; prepare RFPs for professional services and oversee deliverable quality and performance. Partner with Quality, Manufacturing, Regulatory Affairs, and senior site leadership to align engineering priorities with site and program needs.   Experience & Education   Minimum Requirements Demonstrated ability to lead and develop engineering teams in a cross-functional organization, influencing others and fostering collaboration Strong knowledge of cGMP compliance and regulatory requirements in pharmaceutical or biotechnology manufacturing Demonstrated expertise in capital project delivery — design, construction, commissioning, and handover of equipment and