Senior Engineer, MS&T

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 Manufacturing Sciences and Technology (MS&T) department’s primary function is to serve as an agile technical team to support process & technology transfer (e.g., mAbs, fusion proteins, new modalities, etc.), raw materials and consumables, technical writing, and drug substance lifecycle management. The MS&T organization supports the Drug Substance area of the Bloomington facility as well as the Catalent Biologic’s network through client-facing support, on-the-floor or on-call technical coverage, and continuous improvement.

The team is the technical liaison between Process Development (internal or external) and at-scale GMP manufacturing. This function includes drafting and supporting required batch documentation (i.e., gap assessments, reports, batch records, product impact), as well as process modelling and facility fit including initial bill-of-material development. Once production starts, the team provides on-the-floor-support to assist Manufacturing as questions are raised and to look for opportunities where the process could be improved.

The MS&T team provides technical support of late-phase work. The group works with a cross-functional team (including Process Development and Validation) as the program progresses through commercialization.

The Position

This role will be responsible for the technical transfer of processes from Process Development or our clients. It will also involve drafting and review of documentation, compilation, and assessment of process data, and providing technical input for deviation investigations, change controls, and CAPAs. This role will provide on-call and on-the-floor technical support to manufacturing. This position will be client facing and should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.

Relationships

Reports to: Senior Manager, MS&T

Essential Functions

Physical Requirements

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must be able to work in a cleanroom environment, including being able to don cleanroom gowning, for up to 4 hours continuously. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.

Qualifications

• Education & Experience:
• Bachelor’s degree in Science or Engineering required and 3+ years of pharmaceutical industry experience, preferred
• Master’s degree in Science or Engineering and 2+ years of pharmaceutical industry experience, preferred
• 2 years GMP or regulated industry experience, required
• Must be able to read and understand English-written job instructions and safety requirements

• Communication Requirements:
• Excellent written and verbal communications skills with internal and external customers
• Ability to communicate basic technical information to non-technical audiences
• Ability to read, write, and speak clearly in English

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.