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.

As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, 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.

The Position

The validation department consists of four teams; Equipment/Facility, Process, Cleaning and Computer System Validation (CSV). The equipment/facility team initially qualifies and maintains the qualified state of all equipment, facilities and utilities. The process team facilitates at-scale mixing and hold studies, qualifies new products, and maintains the media fill program. The cleaning group qualified equipment used to remove product from manufacturing parts, qualified cleaning methods and performed routine TOC testing. The CSV group qualifies new computer systems and changes to computer systems. All teams support the manufacture of pharmaceutical products and often require direct contact with clients and internal customers across the site. Successful candidates will have excellent communication skills, be self-motivated and action oriented. This department requires individuals to independently problem solve, take ownership of their projects and drive to meet deadlines. There is significant opportunity to learn, try new things and personally impact the business, our clients and ultimately patients taking the life-saving products we manufacture.

Relationships

Reports to: Validation Manager

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

Qualifications

• Education/Experience:
• Bachelor’s degree or higher in a STEM discipline, required
• Master’s/PhD or Certificate (i.e. PE), preferred
• 8+ years of Validation experience
• 4 years GMP or regulated industry experience, required
• Must be able to read and understand English-written job instructions and safety requirements

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.