Process Engineer - Biotech Manufacturing

Process Engineer I - Biotech Manufacturing

Location:

West Lebanon, NH, US

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.

What we offer you:

• Leading pay and annual performance bonus for all positions
• 36
  
  Paid days off including vacation, sick days & company holidays
• Guaranteed 8% 401K contribution plus individual company match option
• 14weeks Paid Parental Leave
• Free access to Novo Nordisk-marketed pharmaceutical products

At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position

Responsible for supporting production through on-floor knowledge and support, documentation to keep production running efficiently, and supporting training of technicians to run according to cGMP requirements. This role will be part of our bioproduction downstream purification 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 broader projects for 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, Process Engineers, 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.

Relationships

Reports to:

Sr. Manager, Process Support

Essential Functions

• 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 initiative 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…