Sr Computer Systems Validation Analyst

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 14weeks 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.

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 improvement, and project coordination
• Coach and mentor personnel, and provide guidance as needed
• Participate in process group meetings and contribute to process group activities
• Execute project activities and process improvement by incorporating cLEAN tools for visual management to track service delivery performance and communicate progress to stakeholders
• Utilize problem solving skills to handle deviations to ensure they are properly documented, investigated, and resolved in a timely manner, as well as ensuring subsequent changes are properly documented, assessed for impact, and implemented in a controlled manner
• Develop and deliver training programs for CSV and…