About the Department

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

What we offer you:

• Leading pay and annual performance bonus for all positions

• All employees enjoy generous paid time off including 14 paid holidays

• Health Insurance, Dental Insurance, Vision Insurance – effective day one

• Guaranteed 8% 401K contribution plus individual company match option

• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave

• Free access to Novo Nordisk-marketed pharmaceutical products

• Tuition Assistance

• Life & Disability Insurance

• 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 IT Compliance Engineer is responsible for ensuring that IT Compliance and Data Integrity (DI) is maintained and controlled within the IT department. This role will also interface with other departments to confirm that they understand their Data Integrity accountabilities. The IT Compliance Engineer mentors and advises junior IT team members to ensure they are applying current, data integrity and compliance principles and practices within the projects.

Relationships

Reports to Manager.

Essential Functions

• Understand and apply ALCOA+ principles when evaluating new systems for implementation or when assisting with remediation(s) of legacy systems
• Collaborate with other departments including Aseptic Production (AP)/ Finished Production (FP)/Quality Control (QC), etc. to enhance/upgrade DI and compliance for their projects, systems, etc.
• Lead discussions in the DI and compliance space
• Assess systems of various complexity for compliance gaps (system/documentation/procedural/etc.) and report out overall compliance risk to allow prioritization in the backlog or project roadmap
• Review & update of procedures that require additional compliance and data integrity content
• Collaborate with the business to assist with audit trail review and DI assessments where the business requires input or needs specific verbiage
• Escalate high impact DI and compliance issues identified in a timely matter to department management
• Manage and involve stakeholders at all levels across the organization, as well as in Corporate IT & Business units
• Ensure systems & processes are compliant & meet regulatory & business requirements
• Ensure department is operating in accordance with internal & external regulations & procedures
• Develop training for data integrity, compliance, and related topics for the department to ensure DI matters are understood, to include onboarding new employees with a compliance mindset
• Review and approve IT Risk Assessments (IRM) from a DI perspective
• Lead and contribute to DI related projects ensuring that Novo Nordisk is adhering to the regulatory requirements
• Represent site Clayton during audits/inspections for IT compliance and data integrity related matters and participate in coaching of automation/IT/System Management/etc. to present their systems in these scenarios
• Investigate IT-related data integrity findings and authoring responses with the full support of the technical resources as needed
• Consult on data integrity related deviations (DVs) and must be trained as DV responsible to ensure ability to contribute to data integrity related issues
• Author and contribute to procedures/strategy at the site to ensure that Novo Nordisk has a compliant framework for operations
• Remain connected to the latest DI expectations from the regulatory authorities, and lead Novo Nordisk in the adoption of more compliant methods of working
• Ensure that archive/retention procedures, strategies, and systems meet regulatory and data retention requirements
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or other relevant field from an accredited university required
• Minimum of four (4) years of experience in computer system validation or quality related discipline experience in pharmaceutical environment required
• Minimum of four (4) years of related experience in stakeholder management & with both exempt & non-exempt employees required
• Demonstrated leadership capabilities preferred
• Experience in regulatory audits & inspections preferred
• Experience working with project teams driving deliverables, tasks, & activities for computer system validation, system remediation, or other related project deliverables preferred
• Understanding of system development lifecycle including validation of computer systems, operation & maintenance & decommissioning of systems required
• Understanding data retention/data archiving required
• Understanding of manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities & laboratories) required
• Expert in GxP documentation practices required
• Proficient in basic computer skills including experience in the use of Microsoft Office required
• Ability to independently write technical documents without supervision required
• Excellent oral & written communication skills required
• Expert in DI gap analysis and remediation required
• Ability to relate well to a wide cross section of stakeholders required
• IT Project Management, System Management & IT Governance 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.