Engineering Manager

Position Summary

The Engineering Manager is a regular, full-time, exempt employee at Kashiv BioSciences, LLC (Chicago, IL). The role leads site engineering, facilities, utilities, and maintenance services, including preventive and corrective maintenance programs, and provides oversight of calibration and qualification/validation support activities. Responsibilities are performed in accordance with company procedures and applicable regulatory, quality, and EHS requirements.

Essential Duties & Responsibilities:

• Follow company policies and procedures, including EHS and safe work practices.
• Lead day-to-day engineering, facilities, utilities, and maintenance support for manufacturing, laboratories, warehouse, and office areas.
• Own the site preventive maintenance (PM) and corrective maintenance (CM) program, including planning, scheduling, execution, and program effectiveness.
• Administer the CMMS and maintenance data, including asset hierarchy, PM job plans, work order management, spare parts, service history, and KPIs.
• Manage utilities and facility systems (GMP and non-GMP) as applicable, which may include HVAC, electrical distribution, compressed air, process gases, vacuum, chilled water, boilers/steam, purified water systems, and BMS/EMS.
• Coordinate troubleshooting and repairs for critical utilities and equipment; communicate risks, impacts, and mitigation plans to stakeholders.
• Drive reliability and continuous improvement through root cause analysis, failure investigations, risk-based maintenance, and performance trending.
• Ensure engineering and maintenance documentation is accurate and current (equipment files, SOPs, work instructions, P&IDs, one-lines, utility schematics, drawings, and as-builts).
• Manage facility and equipment changes through the site change control process, including impact assessments, required approvals, and documentation.
• Support or lead capital and expense projects, including scope development, design review, procurement, contractor execution, commissioning, and closeout.
• Oversee the calibration program, including schedules, vendor management, tolerance requirements, review/approval of records, and resolution of out-of-tolerance conditions per procedure.
• Support qualification/validation activities as required (e.g., URS, risk assessments, protocol execution support, deviations, and closeout) in alignment with site procedures.
• Ensure work is performed in compliance with the site Quality Management System and applicable cGMP/GxP requirements; support internal and external audits/inspections.
• Manage contractors and service providers, including scope of work, permits, site safety requirements, scheduling, and acceptance of completed work.
• Plan and manage shutdowns/maintenance windows as needed to support safe and compliant operations.
• Develop and manage budgets for maintenance, utilities, service contracts, and projects; identify cost and reliability improvements consistent with quality and compliance expectations.
• Supervise, coach, and develop engineering/maintenance staff; set priorities, assign work, and ensure required training and qualifications.
• Partner with Manufacturing, Quality, Validation, QC/Micro, and other stakeholders to plan work, minimize downtime, and resolve issues.
• Perform periodic assessments of utilities/equipment qualifications, maintenance programs, and documentation; develop and execute remediation plans.
• Perform other duties as assigned.