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.

The Position

Primary purpose is to provide the validation of IT Systems for system implementations, changes, & decommissioning. This includes the validation strategy, documentation, protocol generation & execution, & reporting in accordance to regulatory requirements & company standards.

Relationships

Reports to Manager, IT, Validation & Compliance

Essential Functions

• Lead on requests and observation responses by inspectors and auditors
• Participates in defining and executing on the IT Validation and Compliance Team initiatives and goals
• Collaboration with the customer & SMEs on user, functional and design requirements and their traceability through testing verification
• Participate in FAT, SAT, commissioning and IQ/OQ efforts for computerized equipment, analytical instruments, automation/IT systems & business processes
• Author validation documentation: validation plans, system assessments (system impact, security, quality with focus on data integrity), system specifications, SOPs, user guides, summary reports & other required supporting documents to establish the validated state
• Generation & execution of test protocols & system baselines for validated systems per approved timeframes.
• Maintain the validated state of computer systems through change management, periodic review, requalification and data integrity assessments.
• Author decommissioning documentation and ensure data integrity retention requirements are met within the decommissioning plan appropriately (decommissioning plans, assessments, abolishment/updates of documentation, testing protocols & summary reports).
• Validation Deviations & Investigations:
  • Participate in investigations of deviations per approved timeframes.
  • Support validation deviations root cause analysis.
• Strong understanding of process automation code, network architecture, databases, automated instrumentation, and/or application programming; able to develop risk-based qualification strategies for systems in the area(s) of competence.
• Other accountabilities, as assigned.

Physical Requirements

• Must comply with EHS responsibilities for the position.
• Repetition including substantial movement of wrists, hands, and or fingers.
• The ability to speak, listen, and understand verbal and written communication.
• The ability to sit or stand at a desk for extended periods of time.

Qualifications

• Bachelor's Degree in Engineering, Computer Science, or applicable technical degree required OR 10+ years of experience in computer system validation or quality related discipline in lieu of degree.
• Mastery in validation of computer systems, operation, maintenance & decommissioning of systems preferred.
• Mastery in GxP documentation practice preferred.
• Mastery of GAMP compliance, FDA CFR 21 Part 11/EU Annex 11 preferred.
• Proficient in basic computer skills including experience in the use of Microsoft Office required.
• Ability to write protocols & technical documents with limited supervision required.
• Excellent oral & written communication skills required.
• Strong knowledge of regulatory audits & inspections preferred.

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.