Biotech Process Support Associate – Training & Docs

Novo Nordisk A/S; Lebanon, Northern (NH, KY); 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

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.