Process Engineer; Level I-III - Biotech Manufacturing

What We Offer You:

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

• Support production with on-floor knowledge, documentation, technician training to cGMP requirements, preventative maintenance, and equipment repairs
• Assist with design/implementation of manufacturing processes, instrumentation, and equipment start-ups (lab to manufacturing scale)
• Support shop-floor manufacturing issues: deviation investigations, CAPAs, equipment troubleshooting, small scale process development, SOP review, escalation of complex issues, and process confirmations
• Work cross-functionally to ensure operational efficiencies and successful API production; enter sterile clean rooms following gowning/safety/quality policies

• Assist with SOPs, JIs, DVs, and production documentation
• Participate in procedural/automation improvement changes
• Drive minor improvement initiatives and support colleagues
• Develop/write/support production documentation, trend reports, and complex cases; present during audits/inspections
• Maintain communication/alignment; plan/execute compliant activities
  
  Ensure systems/processes are verified and maintained in validated state (FDA/EU/NN)
• Participate in root cause/corrective action teams for investigations
• Write/review protocols, summaries, trend reports, and related validation/verification documentation
• Coordinate scheduling of improvements/critical production activities (including vendors)
• Represent Manufacturing in cross-functional teams and audits/inspections
• Participate in on-call rotations (including weekends/non-business hours)
• Perform duties compliantly and ethically; incorporate Novo Nordisk Way and 10 Essentials

• Bachelor’s degree in engineering or related discipline required
• Bachelor’s + 3 years related experience required
• Medium/large-scale pharmaceutical or biotech process experience preferred

• Follow routine work instructions for projects/assignments
• Knowledge of Automation and GMPs preferred; broad understanding of risk-based verification (e.g., ASTM E2500)
• Good engineering practices; excellent written/verbal communication; high-paced teamwork
• On-call support (evening/night/weekends) and respond within 60 minutes
• Validation technical requirements for biopharma equipment/facilities/instrumentation preferred

Call for accommodation requests only.