Sr Computer Systems Validation Analyst

About the Department At Novo Nordisk, we are committed to improving the quality of life for millions of people worldwide through innovative diabetes care and other chronic disease solutions. What We Offer You Competitive base pay and annual performance bonus 14 paid holidays Health, Dental and Vision Insurance effective day one Guaranteed 8% 401(k) contribution plus individual company match option Family‑focused benefits: 14 weeks paid parental leave and 6 weeks paid family medical leave Free access to Novo Nordisk‑marketed pharmaceutical products Tuition assistance Life and Disability insurance Employee referral awards The Position Provide subject‑matter expertise in Computer Systems Validation (CSV), process improvement, and IT compliance service delivery management across the site. Ensure that IT solutions are implemented and released in compliance with relevant regulations and standards, facilitating seamless transition and handover of projects to service operations with key stakeholders. Act as a governance and continuous improvement enabler supporting product quality, patient safety, and data integrity while contributing to the organization’s goal of improving the lives of patients with chronic diseases. Relationships Reports to Director / Senior Manager / Manager. Essential Functions Participate in all IT solutions validation activities, including IT infrastructure, systems, and computerized equipment supporting laboratories, manufacturing, and business areas such as facilities and warehousing. Ensure compliance with regulations and standards (e.g., 21 CFR Parts 11, EU Annex 11, GAMP requirements). Facilitate, review, approve, and develop validation deliverables (URS, DQ, FMEA, risk assessments, FAT, SAT, protocols, operating and maintenance instructions). 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 comply with regulatory requirements and Novo Nordisk standards, applying lessons learned and staying informed of industry regulatory changes. Perform quality systems activities including document management, change control, deviations, and CAPAs. Write and revise procedures applicable to CSV activities. Work with the engineering group to prepare validation, requalification, and maintenance programs. Facilitate seamless transition and handover of projects to service operations with key stakeholders. Maintain system documentation and processes in compliance with Novo Nordisk standards. Participate as a CSV SME in audits and inspections, providing needed documentation to demonstrate a validated state and release to use. Collaborate with cross‑functional teams to ensure IT solutions meet business needs, are delivered on time and within budget, and are properly documented and released. Ensure all documentation and processes adhere to regulatory requirements and Novo Nordisk standards. Provide leadership and expertise in IT CSV, process improvement, and project coordination. Coach and mentor personnel, providing guidance as needed. Participate in process group meetings and contribute to process group activities. Execute project activities and process improvement using Lean tools for visual management, tracking service delivery performance, and communicating progress. Utilize problem‑solving skills to handle deviations, ensuring proper documentation, investigation, resolution, and controlled implementation of subsequent changes. Develop and deliver training programs for CSV and process improvement initiatives. Communicate effectively with stakeholders at various levels to ensure CSV issues, improvement opportunities, and service delivery meet business needs and align with regulatory requirements. Physical Requirements May move equipment or supplies up to 33 pounds; may be on feet for up to a 12‑hour shift; may require corrected vision of 20/20 or 20/25; may require color vision; may need to work in loud noise environments with hearing protection; ability to work in an open office environment with frequent distractions; travel up to 10% of the time (may vary case by case). Qualifications Bachelor’s Degree in IT, Engineering, Science, or related field from an accredited university (required). Master’s degree in IT, Engineering, Science, or related field from an accredited university (preferred). Minimum of seven years of experience in IT compliance, preferably in pharmaceutical industry API and/or Finished Production Manufacturing. Minimum five years of experience validating and testing IT solutions. Certified Software Quality Engineer (CSQE) preferred. COBIT certification preferred. Lean Six Sigma Green Belt or Black Belt preferred. Experience with electronic application lifecycle software (e.g., HP ALM) preferred. Experience as SME in audits and inspections preferred. Experience with GxP, change management, and deviation handling preferred. Experience with incident, problem, and change management in IT preferred. Excellent writing and communication skills in English (required). Excellent customer service, collaboration, problem‑solving, negotiation, conflict management, and interpersonal skills (required). Excellent planning, organizing, decision‑making, and ability to manage complexity and ambiguity (required). Strong computer skills and MS Office expert (required). We commit to an inclusive recruitment process and equality of opportunity for all applicants. 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. #J-18808-Ljbffr BioSpace, Inc.