What We Offer You
- Leading pay and annual performance bonus
- 14 paid holidays + generous paid time off
- Health, dental, and vision insurance (effective day one)
- Guaranteed 8% 401(k) contribution plus individual company match option
- 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition assistance
- Life & Disability insurance
- Employee referral awards
The Position
Engineer, Process - Drug Substance
- Troubleshoot mechanical problems; identify utility improvements to minimize downtime and reduce energy usage/cost
- Support new and ongoing projects; manage/planning of project budgets and schedules; provide contractor oversight
- Identify, track, forecast, and implement capital expenditure projects (parameters and utility requirements)
- Develop and/or update SOPs; perform in-depth data analysis to resolve complex facility-related problems
- Establish new SOPs or recommend changes based on facility needs; maintain extensive cross-functional communication
Essential Functions
- Support selection/installation of bioprocessing equipment
- Partner with commissioning/validation to implement FDA GMP compliance; draft protocols/reports for validation
- Draft SOPs for equipment operation/maintenance/calibration; maintain quality system compliance
- Act as SME for bioprocessing equipment; manage change control reviews and approvals
- Support audits/corrective actions; identify production improvement opportunities
- Collaborate with Validation, Quality Control, Manufacturing, Process Development, and Facilities; provide technical assistance/training
- Maintain controlled documents; follow safety/environmental requirements
Qualifications
- Bachelorโs in related field + 2+ years relevant experience (or Masterโs/PhD/PharmD with 0+ years as specified)
- 2+ years Project Engineering related experience
Application instructions (accommodation)
- If you need special assistance to apply: call 1-855-411-5290 (accommodation requests only).