Facility Engineering Manager
Synerfac Technical Staffing West Caldwell
- Basic Office Setting - Exposure to Computer Monitor
- Ability to lift or move 1-24 pounds
- Business Travel Required 1-2 trips per year typical
- Business Dress plus ability to Gown for Manufacturing
- I will abide by all cGMP, FDA and DEA regulatory standards
- Manage the facility support / engineering / maintenance staff responsible for power plant, security, pest control, custodians, landscaping, event planning, preventive and on-demand maintenance, calibration, fire suppression systems including non-water systems, energy monitoring, facility and infrastructure construction projects in a GMP pharmaceutical manufacturing site.
- Maintain power plant equipment: electrical, steam, compressed air, HVAC and building environmental control system
- Manage and control the maintenance strategy on a day-to-day basis, including routine, special and shutdown period maintenance
- Ensure regulatory compliance with State, Federal and Local authorities
- Respond to audit requests from regulatory agencies and represent in person during audits.
- Review project plans including cost estimates, timelines, and blueprints; interpret and recommend changes to plans
- Commission and qualify (IQOQ) facility rooms and equipment
- Prepare and manage capex and opex budgets
- Manage project design and construction activities to meet target timelines and costs.
- Write specifications for RFQ documents including necessary calculations
- Coordinate outside contractors and consultants required for the completion of capital projects
- Manage site security, fire and burglar alarm systems. Respond to central station alarms calls 24/7.
- Work overtime, off-shift and weekend work as required to minimize production downtime.
- Ensure satisfactory equipment performance by installing, commissioning, qualifying and maintaining new equipment and major modifications to existing equipment
- Write and execute SOP"s. Change Controls, QAN"s, CAPA"s and other GMP protocols
- Ensure proper engineering documentation practices are met by creating, maintaining and organizing drawings, manuals and other equipment records
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