Facilities Engineer I, SDF

About The Department

Novo Nordisk is dedicated to tackling unmet medical needs for serious chronic diseases like diabetes and obesity, aiming to improve the quality of life for millions globally. In North Carolina, three pharmaceutical manufacturing facilities support injectable and oral treatment supply chains. The Emerging Technologies - Solid Dosage Forms (SDF) facility in Durham, NC, is a 194,000 sq ft tableting and packaging facility for oral treatments for type 2 diabetes. SDF embodies a curious and pioneering spirit, aligning with its growing pipeline of new products and emerging technologies.

The Position

The purpose of this role is to contribute to the establishment of all utilities systems for the OFP site Durham.

Key Responsibilities

• Write/review specifications.
• Participate in design reviews.
• Oversee equipment installation.
• Manage commissioning & qualifications.
• Develop SOPs.
• Develop and train maintenance processes.
• Manage cost, quality, and schedule within the area of responsibility.
• Establish and maintain positive working relationships with internal and external engineering teams and stakeholders.
• Ensure all activities align with Environmental Health & Safety (EHS) program requirements.
• Create and maintain system specifications for black & clean utilities.
• Support design, installation, commissioning, qualification, and training activities for black & clean utilities.
• Provide additional technical support to the project team as required.
• Adhere to all quality & environmental regulations within the area of responsibility.
• Support the technical development of facilities technicians after handover to the Line of Business (LOB).
• Drive continuous process improvement using cLEAN® concepts.
• Maintain and establish standards for procedures and maintenance plans.
• Adhere to all safety and environmental requirements in the performance of duties.
• Perform other accountabilities as assigned.

Physical Requirements

• Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions.
• Routinely operates and 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 and/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, and 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.

Qualifications

• Bachelor's Degree in mechanical, electrical, or chemical engineering or an equivalent combination of education and industry experience.
• With an Associate’s degree in an engineering field of study, a minimum of six (6) years of internal NN experience in clean & black utilities or similar systems is required.
• Two (2) years of engineering experience in a manufacturing facility is preferred.
• Knowledge and experience in the operations, maintenance, and design of cGMP utilities as well as working in a regulated environment (FDA, cGMP, OSHA) is preferred.
• Knowledgeable in black utilities systems including chilled water, plant steam, compressed air, vacuum, and wastewater management is a plus.
• Knowledgeable in clean utilities systems including process water, clean steam, process air, vacuum, and cryogenic storage is a plus.
• Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC & electrical systems is preferred.
• Understanding of technical documents such as URS, SAT, FAT, validation protocols is a plus.
• Understanding of complicated product documentation and standard operating procedures with attention to high-level concepts is a plus.
• Computer literacy with associated systems is preferred.
• Ability to plan, coordinate, and prioritize activities to ensure optimal use of resources in the department is preferred.