Senior Process Engineer - API manufacturing

What We Offer You
- Leading pay and annual performance bonus
- 14 paid holidays and generous paid time off
- Health, dental, and vision insurance (effective day one)
- Guaranteed 8% 401K contribution plus individual match
- 14 weeks paid parental leave and 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition assistance
- Life & Disability insurance
- Employee Referral Awards

The Position
The Process Engineer will support the site to onboard new API manufacturing programs and serve as a key technical resource supporting new chemical API process implementation.

Essential Functions
- Independently lead or support engineering projects from concept design through start-up
- Provide input on capital projects across the lifecycle (URS, process design, equipment/instrument specs and selection, procurement, installation, commissioning/qualification, turnover)
- Provide technical support to manufacturing and research for day-to-day activities (new molecule intro/transfer & scale-up, equipment/process optimization, troubleshooting, continuous improvement)
- Support EHS activities including chemical/hazard assessments (participation in PHAs and PSSRs)
- Develop/review engineering documentation, technical standards, SOPs, protocols, risk assessments, and reports
- Develop and implement cost-effective engineering solutions for equipment, facilities, and utilities
- Support process and automation system designs; promote safe, compliant operations
- Follow all safety and environmental requirements

Qualifications
- Bachelor’s degree in Engineering or Chemistry (required)
- 8+ years relevant experience (required), preferably in pharmaceutical manufacturing
- Knowledge/experience with 2+ of: water, solvent, waste, inert gas, glycol, syltherm, compressed air systems (required)
- Process/equipment design and installation (required)
- Engineering guidelines: CFR, GEP, ASME BPE, ASTM E2500, ISPE (required)
- Ability to start-up and troubleshoot equipment (required)
- Strong writing/communication; ability to work independently and cross-functionally (required)
- Lead projects with external vendors (required)
- Technical leadership on parallel projects (required)
- GMP knowledge (plus); capital engineering projects experience (preferred)
- Pharmaceutical manufacturing operations knowledge (preferred)
- Commissioning/validation experience (FAT, SAT, TOP, IQ/OQ/PQ) (plus)

Application Instructions
Call 1-855-411-5290 for special assistance/accommodation requests only.