Facilities Engineer III - Black Utilities

Novo NordiskClayton, NC
Onsite

About The Position

The purpose of this position is to lead maintenance and optimization of all black utilities systems for the DFP-US facility. Responsibilities include but are not limited to: writing/reviewing specification; design reviews; equipment installation; commissioning & qualifications; SOP development; maintenance development & training; management of cost, quality & schedule within area of responsibility; establishing & maintaining positive working relationship with internal & external engineering team & stakeholders, leadership and mentoring of junior team members. All activities are aligned with Environmental Health & Safety (EHS) program requirements.

Requirements

  • Bachelor's Degree in Mechanical, Electrical or Chemical Engineering or equivalent combination of education & experience required
  • 8-15+ years engineering experience in a manufacturing facility.
  • Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred
  • Thorough knowledge of black utilities systems to include: chilled water, plant steam, compressed air, vacuum, wastewater, cryogenic storage, HVAC.
  • Demonstrated ownership and innovation of black utility systems required
  • Knowledgeable in clean utilities systems to include: WFI, pure water, clean steam, process air, electrical required
  • Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC, & Electrical systems required
  • Thorough understanding of technical documents such as URS, SAT, FAT, Validation Protocols preferred
  • Thorough understanding of complicated product documentation & standard operating procedures with attention to high-level concepts required
  • Computer literacy with associated systems preferred
  • Demonstrated knowledge and proficiency in change control processes and familiarity with validation and commissioning methodology and processes required
  • Proven expertise in planning/organization/execution of project & maintenance activities, following up on results & revising the work plan for complex problems being resolved by cross functional teams preferred
  • Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions.
  • Routinely operates & inspects manufacturing equipment using hands.
  • Ability to be on feet for up to a 12-hour shift.
  • May require corrected vision to 20/25 based on role.
  • May require color vision based on role.
  • Occasionally ascends/descends a ladder.
  • May be required to work at elevated heights.
  • Occasionally works around odorous &/or hazardous materials.
  • May be required to wear latex gloves.
  • Occasionally performs critical job functions in extremely cold work environments.
  • Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment.
  • Ability to work in loud noise environments with hearing protection.
  • Occasionally works in outdoor weather conditions.
  • Able to pass a driving exam for powered industrial trucks.
  • Does not require a valid drivers license.

Nice To Haves

  • Knowledge & experience in the operations, maintenance, & design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) preferred
  • Thorough understanding of technical documents such as URS, SAT, FAT, Validation Protocols preferred

Responsibilities

  • Create & maintain system specifications for black utilities
  • Support all design, installation, commissioning, qualification, training activities for black utilities, as system owner/expert
  • Provide additional technical support to project team as required
  • Adhere to all Quality & environmental regulations within area of responsibility
  • Support technical development of Facilities Technicians after handover to LOB
  • Continuous process improvement using cLEAN® concepts
  • Maintain & establish standards for procedures & maintenance plans
  • All safety & environmental requirements in the performance of duties

Benefits

  • Leading pay and annual performance bonus for all positions
  • All employees enjoy generous paid time off including 14 paid holidays
  • Health Insurance, Dental Insurance, Vision Insurance – effective day one
  • Guaranteed 8% 401K contribution plus individual company match option
  • Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
  • Free access to Novo Nordisk-marketed pharmaceutical products
  • Tuition Assistance
  • Life & Disability Insurance
  • Employee Referral Awards
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