Process Engineer II (Wash & Sterilization)

Novo Nordisk•Clayton, NC

About The Position

The Process Engineer II supports the development and installation of new equipment and processes for Aseptic and Finished Production to meet future business and regulatory requirements. The role focuses on improving system and equipment reliability across core processes while meeting customer, business, and regulatory requirements, with emphasis on people, processes, equipment, and standards. This position supports Aseptic Production—Wash & Sterilization. The ideal candidate has a strong background in cleaning and sterilization processes, including hands-on experience with autoclaves, automated washers, clean-in-place (CIP), and steam-in-place (SIP) systems. Experience supporting, troubleshooting, and optimizing these systems in pharmaceutical manufacturing is preferred. The role works with global teams and vendors on equipment design and development, installs and qualifies new equipment and processes, helps develop process standards, and coaches engineering and maintenance technicians. It also maintains and establishes procedures and maintenance plans and serves as a Diabetes Finished Products (DFP) Technology Network team member for the assigned process.

Requirements

Bachelor's degree in engineering or a related field, or equivalent combination of experience and education.
Minimum of 5 years of engineering experience.
Ability to move equipment or supplies weighing up to 33 pounds within the facility.
Ability to routinely operate and inspect manufacturing equipment using hands.
Ability to strap and unstrap pallets using hands.
Ability to be on your feet for up to a 12-hour shift.
May require corrected vision to 20/20 or 20/25, depending on the role.
May require color vision, depending on the role.
Ability to occasionally ascend and descend a ladder and potentially work at elevated heights.
Ability to occasionally work around odorous or hazardous materials.
Ability to wear latex gloves if required.
Ability to work in extremely cold environments, confined spaces, and loud-noise environments with hearing protection if required by the role.
May be required to obtain a motorized vehicle license and operate a motorized vehicle, depending on the role.

Nice To Haves

cLEAN® 2 Star or Six Sigma Green Belt certification.
Knowledge of Instrument and Electrical systems, mechanical systems, Control/SCADA/PLCs, process improvement methodologies, Root Cause Analysis (RCA), and Reliability Centered Maintenance (RCM).
Expertise in planning, organizing, and executing maintenance activities and following up on results.
Experience revising work plans for complex problems resolved by cross-functional teams.
Strong background in cleaning and sterilization processes, including hands-on experience with autoclaves, automated washers, CIP, and SIP systems.
Experience supporting, troubleshooting, and optimizing cleaning and sterilization systems in pharmaceutical manufacturing.

Responsibilities

Develop new equipment and processes for Aseptic and Finished Production areas.
Coach and mentor Engineering and Maintenance Technicians.
Support technical development of processes and process standards.
Employ advanced cLEAN® tools in problem solving, project management, and change management.
Work with global teams and vendors on technical equipment design and development.
Install and qualify new equipment and processes as part of the engineering team.
Work with global teams to develop new equipment and pilot processes.
Establish and maintain standards for procedures and maintenance plans.
Serve as a Diabetes Finished Products (DFP) Technology Network team member for the assigned process.
Improve system and equipment reliability to meet customer, business, and regulatory requirements.