Process Engineer; Level I-III - Biotech Manufacturing

Process Engineer (Level I-III) - Biotech Manufacturing

Location:

West Lebanon, NH, US

This role will be part of our bioproduction upstream cell culture Process Support team, dedicated to one of our manufacturing suites. Responsible for supporting production through on‑floor knowledge and support, documentation to keep production running efficiently, supporting training of technicians to run according to cGMP requirements, ensuring routine preventative maintenance and equipment repairs are carried out correctly. May be responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start‑ups from the laboratory through manufacturing scale.

The Process Engineer will work alongside Process Associates and Process Scientists and may support day‑to‑day issues in manufacturing such as: deviation investigations, CAPAs, equipment troubleshooting, small‑scale process development, SOP review, escalating complex issues to appropriate stakeholders, or participating in process confirmations on the shop floor. This role will work cross‑functionally with groups/departments across our site to ensure operational efficiencies and successful production of API onsite.

This role will require entering our sterile cleanroom areas while following all relevant gowning, safety, and quality policies. Prior experience in a GMP environment or life science industry is a plus for this role.

The job level and title of hired candidate will be commensurate with experience. This is an onsite based position Monday‑Friday at our bioproduction facility in West Lebanon, NH.

Reports:
Sr. Manager, Process Support

• Assist with SOPs, JIs, DVs and other production documentation to 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 shopfloor. Drive an own minor improvement initiatives and support colleagues
• Develop, write and support any documentation needed in the production as well as supporting trend reports and complex cases owned by the area. Presents this during audits/inspections
• Maintain effective communication and ensure alignment in coordination with appropriate teams
• Plan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activities
• Ensures systems and processes are verified and are kept in a validated state in accordance with FDA, EU and NN requirements
• Actively participate in cross‑functional teams to determine the root cause and corrective actions for problems associated with investigations
• Write and review protocols, summary and trend reports and other documentation associated with ongoing production, verification, and validations
• Coordinate scheduling of improvement and critical production activities within own area, across areas and as well as 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
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates 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 GMPs requirements preferred
  • Broad understanding of science and risk‑based verification (I.E. ASTM E2500)
  • Knowledge of good engineering practices
  • Excellent written and verbal communication skills a must
  • Excellent communication…