Project Engineer (Biotech Focus)

About the Department

Novo Nordisk’s manufacturing facility in West Lebanon, New Hampshire produces a global supply of hemophilia and growth hormone product lines, as well as next-generation cutting-edge medications. This site is a tight-knit, supportive community focused on ethics, quality, and a patient-first mindset. We offer opportunities, resources, and mentorship to help you grow and build your career.

Purpose

This role supports projects for the implementation of manufacturing initiatives within our GMP bioproduction facility. You will assist the project management team with capital and operational excellence projects, develop process and equipment improvements, and drive production-related optimizations and capacity enhancements. The position reports to the Sr. Manager of Project Engineering and involves cross-functional collaboration, vendor coordination, and onsite work five days a week at our West Lebanon, NH facility.

Responsibilities

• Lead process and equipment troubleshooting to support deviations, corrective actions, and related issues.
• Ensure systems and processes remain verified and validated in accordance with FDA, EU, and Novo Nordisk requirements.
• Participate in the development and implementation of procedural or automation improvements.
• Engage in design and hazard reviews for plant expansions or process changes, serving as the technical point of contact for contractors.
• Plan and execute projects in a compliant manner, ensuring timely delivery of activities.
• Actively participate in cross-functional teams to determine root causes and corrective actions for investigations.
• Write and review protocols, summary reports, and documentation related to production, verification, and validations.
• Coordinate scheduling of improvement and critical production activities with internal teams and external vendors.
• Initiate and manage projects, including budget tracking, scope development, risk assessments, cost estimates, and purchase order requisitions.
• Supervise contractors or interns, providing mentorship, performance reviews, and troubleshooting support.
• Participate in on-call rotations, including weekends and non-business hours, to provide support.
• Perform all duties in compliance with healthcare laws, regulations, and industry codes, incorporating Novo Nordisk’s ethical standards.
• Other duties as assigned.

Requirements

• Bachelor’s degree in engineering or a related discipline (required).
• Master’s degree in engineering or a related discipline (preferred).
• Bachelor’s degree with five (5) years of related experience (required).
• Master’s degree with three (3) years of related experience (preferred).
• Experience in medium to large-scale pharmaceutical or biotechnology processes (preferred).

Skills

• Ability to work independently with minimal instruction on routine tasks; general guidance on new assignments.
• Knowledge of automation, GMPs, compliance, and regulatory requirements.
• Excellent communication skills and ability to thrive in a high-paced, team-oriented environment.
• Must remain accessible during on-call periods and respond within sixty (60) minutes.

Physical Requirements

• Ability to climb, stoop, kneel, crouch, crawl, reach, stand, and walk.
• Ability to push, pull, lift, finger, feel, and grasp.
• Repetitive movement of wrists, hands, and/or fingers.
• Lifting up to 33 lbs/15 kg occasionally, up to 30 lbs frequently, and up to 10 lbs constantly.
• Visual acuity for reading, writing, analysis, and inspection tasks.
• Exposure to noise, varying temperatures, narrow aisles, and atmospheric conditions such as odors, fumes, and dust.

Local and international travel: 0-10%.