Engineering Manager

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

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.