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.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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 12 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 validation standards) are maintained and controlled within the IT department. This role will interface with other departments to ensure compliance within projects and initiatives at site Clayton. The IT Compliance Engineer supports technical IT and automation resources to ensure they are applying current validation, data integrity (DI), and compliance principles and practices within the projects.

  Relationships

  Manager.

  Essential Functions

• Understand and apply ALCOA+ principles when evaluating new systems for implementation or when assisting with upgrades of legacy systems

• Collaborate with other departments including Aseptic Production (AP)/ Finished Production (FP)/Quality Control (QC), etc. To enhance/upgrade validation and compliance for their projects, systems, etc.

• Support discussions on compliance within DD&IT and assist IT and automation technical personnel with compliance documentation including CRs, deviations (DVs), SOPs, and validation

• Assess systems of low/medium 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 procedures that require additional compliance and data integrity content

• Collaborate with the line of business (LoB) to assist with compliance assessments or within documentation that requires IT compliance input

• Escalate high impact DI and compliance issues identified in a timely matter to department management

• Engage and involve stakeholders for input on changes at all levels across the site Clayton, as well as interface with Corporate IT and process groups

• Ensure systems are compliant & meet regulatory & business requirements

• Ensure the IT department is operating in accordance with internal & external regulations & procedures

• Support 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

• Support IT and Automation with Compliance Template creation/approval within Servicenow/Octoplant

• Review and approve IT Risk Assessments (IRM) as an IT risk manager

• Contribute to DI related projects ensuring that Novo Nordisk is adhering to the regulatory requirements

• Support site Clayton during audits/inspections for IT compliance and validation related matters

• Present IT topics to auditors/inspectors and support coaching of items going into the audit room

• Investigate audit findings related to IT Compliance and author responses with the full support of the technical resources and senior IT compliance personnel

• Consult on validation and compliance related (DVs). Must be trained as DV responsible to ensure ability to contribute to compliance related gaps

• 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 expectations from the regulatory authorities, and support Novo Nordisk in the adoption of compliance innovations

• 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 two (2) years of experience in computer system validation or quality related discipline experience in pharmaceutical environment required

• Minimum of two (2) years of related experience in stakeholder management & with both exempt & non-exempt employees required

• Leadership capabilities preferred

• Experience in regulatory audits & inspections preferred

• Experience working with project teams authoring deliverables, & completing actions 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

• Advanced understanding of GxP documentation practices required

• Proficient in basic computer skills including experience in the use of Microsoft Office required

• Ability to author technical documents, CRs, DVs, SOPs, etc. with input from IT/Automation technical SMEs required

• Advanced oral & written communication skills required

• Proficient in compliance gap analysis for documentation/systems 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.