Process Engineer; Level I-III - Biotech Manufacturing

About the Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting‑edge medications.

• Leading pay and an annual performance bonus for all positions
• 36 paid days off including vacation, sick days & company holidays
• Health, dental and vision insurance
• Guaranteed 8% 401(k) contribution plus individual company match option
• 14 weeks paid parental leave
• Free access to Novo Nordisk‑marketed pharmaceutical products

This role is part of the bioproduction upstream cell culture Process Support team, dedicated to one of our manufacturing suites. The Process Engineer supports production on‑floor, documents processes to keep production running efficiently, trains technicians to run in accordance with cGMP requirements, and ensures routine preventative maintenance and equipment repairs are performed correctly. The engineer may assist with design and implementation of manufacturing processes, instrumentation and equipment start‑ups from the laboratory through manufacturing scale, support day‑to‑day manufacturing issues such as deviation investigations, CAPAs, equipment troubleshooting, small‑scale process development, SOP review, and participate in process confirmations on the shop floor.

The role works cross‑functionally with groups and departments across the site to ensure operational efficiencies and successful production of API onsite and requires entry into sterile cleanroom areas following all relevant gowning, safety and quality policies. Prior experience in a GMP environment or life science industry is a plus.

The position is onsite (Monday‑Friday) at our bioproduction facility in West Lebanon, NH. The job level and title will be commensurate with experience.

Reports to:

Sr. Manager, Process Support

• Assist with SOPs, JIs, DVs and other production documentation for the shopfloor
• Participate in the development and implementation of procedural or automation improvement changes
• Participate in production‑driven improvements to the process and equipment on the shopfloor; drive own minor improvement initiatives and support colleagues
• Develop, write and support documentation needed in production, including trend reports and complex cases owned by the area. Present during audits/inspections
• Maintain effective communication and ensure alignment with appropriate teams
• Plan and execute activities according to timeline, ensuring timely delivery of own workload
• Ensure systems and processes are verified and kept in a validated state in accordance with FDA, EU and NN requirements
• Participate in cross‑functional teams to determine root cause and corrective actions for investigations
• Write and review protocols, summary and trend reports associated with ongoing production, verification and validation
• Coordinate scheduling of improvement and critical production activities within own area, across areas and with outside vendors as needed
• Represent the Manufacturing department in cross‑functional teams (Manufacturing, Engineering, Technical Support and Quality groups) and present relevant material during audits/inspections
• Participate in on‑call rotations, including weekends and non‑business hours, to provide support
• Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporate the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
• Other duties as assigned

• Education and
  
  Certifications:
  • Bachelor's degree in engineering or related discipline required
• Work Experience:
  • Bachelor's degree with three (3) years related experience required
  • Medium to large scale pharmaceutical or biotechnology process experience preferred
• Knowledge, Skills and Abilities:
  • Ability to follow routine work instructions for new and ongoing projects and assignments
  • Knowledge of automation and GMP requirements preferred
  • Broad understanding of science and risk‑based…