Process Associate I - Biotech Manufacturing

Novo Nordisk A/S; Lebanon (NH); Hybrid; USD 65,000 - 95,000; Full time

Benefits offered by this job

Leading pay and bonus

36 paid days off including vacation, +

401K with company match up to 8%

14 weeks paid parental leave

Free access to Novo Nordisk products

Job summary

Novo Nordisk A/S is seeking a Process Associate I to support downstream process operations at the West Lebanon, NH bioproduction site. The role emphasizes training, deviations handling, change control, and project execution to keep production running efficiently while adhering to cGMP requirements.

The position works cross-functionally, reviewing quality records and training technicians to run processes per QMS, with on-floor support and process documentation responsibilities.

Qualifications

• Requires functional understanding of cGMPs, established manufacturing practices and quality regulations.
• Ability to understand and execute established written instructions is essential.
• Strong organizational skills with attention to detail.
• Demonstrates practical lean manufacturing principles.
• Analytical abilities and problem-solving skills.
• Excellent communication skills—clear to all audiences.
• On-call availability with responsive timing (60 minutes).

Responsibilities

• Liaison between Production Support and Manufacturing for process/equipment improvements and data analysis.
• Review and approve completed process documentation.
• Train others on the manufacturing process and QMS systems.
• Revise/create SOPs, batch records and related documentation.
• Investigate and write Deviation reports using Root Cause Analysis.
• Incorporate process improvements and cost-reduction projects into manufacturing.
• Lead multi-disciplined projects with minimal supervision.
• Support Health Authority inspections and quality systems.
• Provide hands-on manufacturing support as needed for coverage.
• Respond to on-call rotations including weekends and non-business hours.

Skills

cGMP knowledge

Lean manufacturing

Analytical thinking

Problem solving

Excellent communication

On-call responsiveness

Education

High School diploma

Bachelor’s degree preferred

Job description

Process Associate I - Biotech Manufacturing

Facility: 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
• 36Paid 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

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.

Relationships

Reports to: Sr. Manager, Process Support

Essential Functions

• 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.

Qualifications

• 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 experience preferred
  • Pharmaceutical or biotechnology experience strongly preferred
• Knowledge, Skills and Abilities:
  • Requires functional understanding of cGMPs, established manufacturing practices and procedures and compliance with quality regulations and guidelines
  • Ability to understand and execute established written instructions is essential
  • Organizational skills and an ability to perform assignments with a high degree of attention to detail
  • Demonstrate a practical understanding of lean manufacturing principles
  • Analytical abilities and problem-solving skills
  • Excellent communication skills-articulates ideas and concepts clearly to all audiences
  • Employee must remain accessible during on-call period and must be able to provide support/respond within sixty (60) minutes

Physical Requirements

The ability to finger, climb and walk. The ability to speak, listen and understand verbal and written communication. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. This position may lift up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects. Visual acuity to perform close activities such as: reading, writing and analysing; and to determine the accuracy, neatness and thoroughness of work assigned or to make general observations.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.