Engineering Manager

West Caldwell, New Jersey

Employer: System One Holdings, LLC
Industry: 
Salary: Competitive
Job type: Full-Time
Title: Facility Engineering Manager

Location: West Caldwell, NJ

Schedule: M-F Full Time

Type: Direct Hire

Responsibilities:
  • Business Travel Required 1-2 trips per year typical
  • Business Dress plus ability to Gown for Manufacturing
  • 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 company 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
Requirements:
  • Bachelor's degree in Facilities Engineering, Mechanical Engineering or Electrical Engineering.
  • 15+ years experience as a Facility Engineering Manager in a GMP facility
  • Proven track record in driving large capital A&E projects ($1M+) to completion
  • Experience with DEA compliant construction requirements for controlled substances
  • Working knowledge of building codes and the NEC
  • Advanced skill level in MSOffice applications, especially Excel
  • Basic reading, writing, math, and verbal skills
  • Able to wear safety glasses, hearing protection, full face/half mask respirator, latex gloves, Tyvek suit and other safety equipment as needed
  • Basic use of tools and equipment
  • Ability to create and edit drawings in 2D AutoCAD
Created: 2024-09-06
Reference: 325947
Country: United States
State: New Jersey
City: West Caldwell

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