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IT Compliance Engineer | Engineer in Engineering Job in Clayton NC | 7325113436

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IT Compliance Engineer

Location:
Clayton, NC
Description:

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 and 6 weeks paid family medical leave:Free access to Novo Nordisk:marketed pharmaceutical products:Tuition Assistance:Life and 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 stylemargin:bottom:11.0px::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 and 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 and 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 and meet regulatory and business requirements:Ensure the IT department is operating in accordance with internal and external regulations and 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 projec
Industry:
Insurance
Posted:
July 4 on Tip Top Job
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