Computer System Validation Csv Jobs in Raleigh, NC

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 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 Product Supply Aseptic Manufacturing (PS AM) 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 PS AM, 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 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

Manage systems throughout their lifecycle, provide project oversite and drive deliverables, partner with key stakeholders, & ensure adherence to the Novo Nordisk and regulatory requirements for assigned IT Systems. Ensure processes are in place for system maintenance & operation according to relevant regulatory authorities (GxP, financial, personal data protection, etc.).

Relationships

Reports to Supervisor, IT System Management & Validation.

Essential Functions

• Systems Management:
  • Ensures system compliance with relevant internal SOPs & guidelines as well as external requirements (21CFR Part 11, Personal Data Protection, SARBOX, etc.)
  • Reviews & maintains all IT CSV validation/system decommissioning documentation in accordance to regulatory & Novo Nordisk requirements
  • Responsible for the system life cycle management & suggests inputs for the IT roadmap
  • Documents operation & maintenance of the system (incident management, contract/SLA management, data integrity/retention/archive, continuity/recovery plans)
  • Performs system reviews to ensure basic IT controls are in place & in control to ensure compliance/security of the system
  • Acts as a peer mentor providing reviews and input to documentation prepared by other team members
  • Ensures appropriate testing (i.e., FAT, SAT, UAT, IQ, OQ, PQ, &/or GEP) is in place to ensure IT requirements are met
  • Participates in root cause analysis for deviations within supported IT Systems to ensure effective corrective actions are identified & implemented
  • Represents IT systems in connection with audits and inspections
• Documentation:
  • System documentation including operational manuals, system architecture, & data flow completion
  • Works with subject matter expert (SME) to ensure system documentation is compliant with local, corporate & regulatory regulations
  • Documentation of system configuration baselines
• Security:
  • Approves appropriate access to new users & removes access as necessary
  • Works with IT Security/SME to ensure controls are in place & documented
  • Performs annual system evaluation
• System Support:
  • Serves as the escalation point for system support
  • Ensures end user training is in place, as required
  • Prepares support agreements with internal & external sources
  • System Projects: Performs activities assigned within agreed timelines
  • 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 Computer Science or Engineering, or similar applicable technical degree in relevant field required
• Minimum five (5) years of operation & maintenance of IT systems preferably within the pharmaceutical industry required
• Experience with production manufacturing; IT projects & management of IT systems required
• Knowledgeable & have an understanding in the following areas: required
  • IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11 required
  • System development lifecycle including validation of computer systems, operation & maintenance, & decommissioning of systems required
  • 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 with Microsoft Office required
• Ability to independently review & approve protocols & technical documents in compliance with regulatory & Novo Nordisk requirements required
• Excellent oral & written communication skills required
• Experience in regulatory audits & inspections required
• Experience in project teams driving deliverables, tasks, & activities for computer system validation required
• Expert in utilizing appropriate root-cause analysis tools & techniques required
• Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today.

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.