Principal Engineer, Validation

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

 

Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.  

 

What we offer you:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance 
8. Life & Disability Insurance
9. Employee Referral Awards

 

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.  Are you ready to realize your potential?  Join Team Novo Nordisk and help us make what matters.

 

Position

Responsible to lead validation strategy and mentor engineers/senior engineers on execution.

 

Relationships

Reports to Manager, Validation.

 

Essential Functions

• Equipment Validation
  • Lead execution validation protocols including installation / operational qualifications and requalification’s on process equipment and utilities
  • Revise validation documents including protocols and SOPs
  • Access data and generate reports from control systems
  • Compile data for qualification reports; complete and review calculations and perform technical
  • Review of validation documents
  • Lead investigations, change controls, and similar activities
  • Draft new protocols for systems similar to existing site systems
  • Develop qualification strategies and documents for novel systems
  • Present qualifications to clients, auditors, and inspectors
  • Coordinate with other internal groups including QC, engineering, automation, and production to complete execution of validation protocols and other tasks
  • Demonstrate familiarity with industry guidance documents for equipment validation
  • Execute validation tasks and projects to achieve project timelines
  • Review work orders and similar records for validation impact
  • Train new team members and provide technical oversight of work performed by Technicians, Associate Engineers and/or Engineers
  • Strong understanding of guidance documents from FDA, EMA, PDA, ISPE, ASME, ISO, and other industry organizations
  • Lead complex equipment validation projects
  • Review and approve deviations relevant to equipment validation
  • Understand other validation technical disciplines, such as cleaning, computer system validation, and process validation, and be able to integrate equipment validation into broader projects
  • Aware of regulatory trends, industry best practices, and technological improvements related to equipment validation
  • Lead response to regulatory requests and observations