Sr Computer Systems Validation Analyst

About The Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. 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 newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

• 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

Provide subject matter expertise in Computer Systems Validation, process improvement, and IT compliance service delivery management across the site. Ensure that IT solutions are implemented and released to use in compliance with relevant regulations and standards facilitating the seamless transition and handover of projects to service operations with key stakeholders. Ensure governance and continuous improvement as an enabler supporting product quality, patient safety, and data integrity and contributes to the organization's goals of improving the lives of people with chronic diseases.

Reports to Director / Senior Manager / Manager.

• Participate in all IT solutions validation activities including but not limited to: IT Infrastructure, IT Systems, and Computerized Equipment’s supporting Laboratories, Manufacturing, and Business Areas like Facilities and Warehousing
• Ensure that IT solutions are compliant with relevant regulations and standards, e.g. 21 CFR Parts 11, EU Annex 11, and GAMP requirements among others
• Facilitate, review, approve and as required develop validation deliverables including but not limited to URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ), Operating and Maintenance Instruction
• Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies
• Provide guidance and support to project teams on validation and qualification requirements
• Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards while working to identify efficiencies in the CSV program approach, applying lessons learned, and stay informed of industry regulatory changes as it applies to CSV
• Perform assigned Quality Systems activities including Document Management system, Change Control, Deviations, and CAPA’s
• Writing and/or revising procedures applicable to CSV activities
• Work in collaboration with the Engineering group to prepare the validation, requalification, and maintenance program
• Facilitate the seamless transition and handover of projects to service operations with key stakeholders
• Maintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements
• Participate as a CSV SME in audits and inspections and provide needed documentation to demonstrate validated state and release to use
• Collaborate with cross-functional teams to ensure that all IT solutions meet business needs, are delivered on time & within budget, and are properly documented and released to use
• Ensure that all documentation and processes are following regulatory requirements and Novo Nordisk standards
• Provide leadership and expertise in IT CSV, process…