Job Type
Full-time
Description
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.
Requirements
Position Requirements and Qualifications Education:- BS or MS Degree in related Engineering field.
Experience:- Minimum 3 years of experience in a biotech, pharmaceutical, or medical device environment; project management experience preferred.
- 3-5 years of supervisory experience in a biotech, pharmaceutical, or medical device environment.
Special Skills:- Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
- Demonstrated technical problem-solving skills, including root cause analysis and risk-based decision making.
- Working knowledge of CMMS systems, maintenance planning, and KPI tracking.
- Clear written and verbal communication skills, including technical writing and documentation practices.
Work Environment & Physical Demands: - Work at a desk doing computer work (reading, editing, writing documents) is also required.
- Works in machinery rooms, clean rooms, and laboratories.
Noise:- No extraordinary noise levels.
Standing/Lifting:- Must be able to move around the facility to reach various equipment.
- Must be able to lift at least 25 lbs.
Visual:Stress:- Work requires managing multiple priorities and responding to urgent equipment and facility needs.
Travel:- Occasional trips for equipment FATs at vendor sites, or other business needs (lasting up to 2 weeks at a time). Potential for international travel. No regularly scheduled travel.
Supervisory Responsibility, if any : Yes
