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

The Position:
- 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 cleanrooms following gowning/safety/quality policies

Essential Functions:
- 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

Qualifications:
- 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

Skills/Abilities (required unless noted):
- 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

Application instructions:
- Call 1-855-411-5290 for accommodation requests only.