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

• Ensure that all documentation and processes are following regulatory requirements and Novo Nordisk standards

• Leadership and Collaboration:

• Provide leadership and expertise in IT CSV, process improvement, and project coordination

• Collaborate with cross-functional teams to ensure that IT solutions meet business needs and are delivered on time and within budget

• Coach and mentor personnel, and provide guidance as needed

• Participate in process group meetings and contribute to process group activities

• Ensure that all activities are aligned with Novo Nordisk Way Essentials and support the organization's mission to improve the lives of people with chronic diseases

• The Senior CSV Analyst will spend the majority of its time on project activities and process improvement within these areas of accountability (key essential functions above), incorporating cLEAN tools for visual management to track service delivery performance and communicate progress to stakeholders; Problem solving, handling deviations ensuring that deviations are properly documented, investigated, and resolved in a timely manner, and planning ensuring that changes are properly documented, assessed for impact, and implemented in a controlled manner. It also develop and deliver training programs for CSV and process improvement initiatives

• The Senior CSV Analyst is responsible for communicating effectively with stakeholders at various levels of the organization to ensure that CSV issues, improvement opportunities, and service delivery meet business needs and are aligned with regulatory requirements and Novo Nordisk standards. Moreover, will also perform other duties as assigned

  Physical Requirements

  0-10% overnight travel required. This position may lift up to 33lbs/15kg occasionally, and/or up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetition including substantial movement of wrists, hands, and or fingers. The ability to speak, listen, and understand verbal and written communication. The ability to stoop, kneel, crouch, reach, stand, and walk. The ability to push, pull, lift, finger, and grasp. Visual acuity to perform close activities such as: reading, writing, and analyzing; operating a motor vehicle or heavy equipment, and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including noise, inside and outside conditions including temperature changes; atmospheric conditions including odors, fumes, and dust.

  Qualifications

• Education and Certifications:

• Bachelor’s degree in Information Technology field or related field

• Master’s degree in a related field is preferred

• Certifications:

• Certified Software Quality Engineer (CSQE) is preferred

• COBIT Certification is preferred

• Lean Six Sigma Green Belt or Black Belt is preferred

• Work Experience:

• 7+ years of experience in IT compliance, preferably within the pharmaceutical industry API and/or Finish Production Manufacturing.

• 5+ years of experience on Validation and Testing of IT Solutions.

• Experience with electronic application lifecycle software, from requirements gathering to testing and deployment, preferrable HP ALM.

• Experience as SME participating in Audits and Inspections.

• Experience on GxP, change management and deviation handling.

• Experience with Incident, Problem, and Change Management in IT.

• Knowledge, Skills, and Abilities:

• Excellent writing and communication skills, in English

• Excellent customer service skills and ability to collaborate effectively in a team environment

• Excellent problem solving, negotiation, conflict management, and interpersonal skills

• Excellent planning, organizing, decision making and deal with complexity and ambiguity

• Strong computer skills and MS Office Expert

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

  At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

  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.