Process Engineer II - III; Downstream Purification

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. It's not your average production site - it's a tight-knit, supportive community working together to contribute to a better tomorrow for our patients.

Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We're looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

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. Develop ideas and improvements for the production process and equipment - individually and via close collaboration with colleagues and stakeholders. Participate in and drive production related projects and improvements to support optimizations and capacity improvements as well as complex investigations across Departments.

This role will be part of our bioproduction downstream purification Process Support team, dedicated to one of our manufacturing suites. Will be expected to independently lead and execute 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.

Reports to Sr. Manager, Process Support

• Leads process and equipment troubleshooting to support deviations, corrective actions and related issues
  
  Ensures systems and processes are verified and are kept in a validated state in accordance with FDA, EU and NN requirements
  
  Participate in the development and implementation of procedural or automation improvement changes
  
  Participate in design and hazard reviews of plant expansions or process changes and serving as the technical point of contact or user representative for contractor services including design, fabrication, installation and validation
  
  Plan and execute according to timeline and in a compliant manner and ensure timely deliveries of own activities
  
  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
  
  Support validation of new and existing equipment, processes and instrumentation as needed
  
  Represent the Manufacturing department in cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) and present relevant material during audits/inspections
  
  Own equipment and process in the production area and keep these within compliance
  
  Initiate and manage projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions and controlling payment schedules
  
  Regular supervision of contractor or intern reports including mentoring, performance reviews, project and support advice as well as troubleshooting for the…