Senior Computer Systems Validation Analyst (Remote)

About the Department     

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

 

 

What we offer you:

• Leading pay and annual performance bonus for all positions
• 36 Paid days off including vacation, sick days & company holidays
• Health Insurance, Dental Insurance, Vision Insurance
• Guaranteed 8% 401K contribution plus individual company match option
• 12 weeks Paid Parental Leave
• Free access to Novo Nordisk-marketed pharmaceutical products

 

The Position

The purpose of the Senior CSV Analyst (Remote) position is to provide subject matter expertise in Computer Systems Validation, process improvement, and IT compliance service delivery management across the site. The Senior CSV Analyst ensures 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. It plays a critical role in ensuring 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.

 

Essential Functions

• Computer Systems Validation Expert:
  • Involved in all IT solutions validation activities what includes but is 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 what includes but is 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. Work to identify efficiencies in the CSV program approach. Work to apply 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
• CSV Service Delivery Management:
  • 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 an 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 are properly documented and released to use