Project Engineer (Biotech Focus)

About the Department

Novo Nordisk’s manufacturing facility in West Lebanon, NH produces a global supply of hemophilia and growth hormone product lines, as well as next-generation cutting-edge medications. This tight-knit, supportive community prioritizes ethics, quality, and a patient-focused mindset. The site offers opportunities, resources, and mentorship to grow and build your career.

About the Role

This role supports projects for the implementation of manufacturing initiatives within our GMP bioproduction facility. You will collaborate with the project management team on 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 works cross-functionally across the site, including with external vendors and contractors. This is an onsite role based in West Lebanon, NH, requiring five days a week on location.

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 contractor services, including design, fabrication, installation, and validation.
• 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 and trend reports, and other documentation related to production, verification, and validations.
• Coordinate scheduling of improvement and critical production activities within and across areas, including with outside vendors.
• Initiate and manage projects, including tracking budgets, creating scopes of work, justifications, risk assessments, cost estimates, purchase order requisitions, and payment schedules.
• Supervise contractor or intern reports, providing mentoring, performance reviews, project advice, and troubleshooting support for complex manufacturing issues.
• Participate in on-call rotations, including weekends and non-business hours, to provide support.
• Perform all duties in a compliant and ethical manner, adhering to healthcare laws, regulations, and industry codes.
• Incorporate the Novo Nordisk Way and 10 Essentials in all activities and interactions.
• Other duties as assigned.

Qualifications

• 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).
• Medium to large-scale pharmaceutical or biotechnology process experience (preferred).

Skills

• Ability to work independently with minimal instructions on routine tasks; general guidance provided for 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.
• Capability to speak, listen, and understand verbal and written communication.
• 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, analyzing, and visual inspection.
• Exposure to noise, inside/outside conditions, narrow aisles, temperature changes, and atmospheric conditions such as odors, fumes, and dust.

Local and international travel: 0-10%.