Process Associate - Biotech Manufacturing

Process Associate I - Biotech Manufacturing

Facility:
Manufacturing

Location:

West Lebanon, NH, US

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 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?

This position has primary responsibility to support manufacturing operations in one of our downstream process support teams. Focus areas may include Training, Documentation, Deviations, Change Control and Projects. Drives the coordination and execution of process and equipment improvement initiatives, reviews completed quality records, generates quality deviation responses, drive investigations and has ability to train technicians on processes and QMS systems. 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 work cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API. This role will require entering our sterile cleanroom areas while following all relevant gowning, safety, and quality policies.

This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH.

Reports to:

Sr. Manager, Process Support

• Liaison between Production Support and Manufacturing for the coordination of process/equipment improvements and data trending/analysis
• Review/approval of completed process documentation
• Ability to train others on the manufacturing process and QMS systems
• Revise and create documentation (SOP, batch records, FT’s) associated with the manufacture of product, requiring minimal direction
• Ability to investigate and write up Deviation events utilizing Root Cause Analysis
• Incorporate pre-planned process improvements and cost reduction projects into manufacturing
• Ability to take on and manage multi-disciplined projects, with minimal supervision
• Understanding/application of quality systems
• Support of Health Authority inspections
• Possesses technical and systems knowledge and can research information outside of knowledge base
• May need to support hands-on manufacturing within the given area for production coverage
• Has ability to recognize problems and recommend solutions to problems based on technical understanding of the process and equipment
• Support activities in other departments as instructed by manager
• 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:
  • High School diploma or equivalent required
  • Bachelor’s degree in science or engineering preferred
• Work Experience:
  • High School diploma or equivalent with six (6) years relevant manufacturing experience required
  • Bachelor’s degree or equivalent with two (2) years of…