QA IT Validation Area Specialist Job:
Novo Nordisk

Novo Nordisk
Clayton North Carolina
At Novo Nordisk, we want to make a difference. For more than 95 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

Help us bring quality to life. We are currently seeking top talent for our two pharmaceutical manufacturing facilities in Clayton, NC.

Working at our filling and finishing facility (DFP)

Make What Matters
Our 457,000 square foot aseptic “fill and finish” manufacturing facility in Clayton, NC, currently employs more than 850 people. The facility is part of a global network of manufacturing sites responsible for several key steps in the diabetes treatment manufacturing process, including sterile formulation, filling, inspection, device assembly and packaging.

Producing medicines is a special responsibility. Our employees are passionate about what they do, knowing that their work makes a difference to millions of people who rely on our products every day.

Join us and help make what matters.

Position Purpose:
Responsible for Quality support of IT Infrastructure, database & automation validation activities. Be the site compliance expert for the planning, documenting & execution of qualification & validation of IT/Automation systems & processes

  • Primary quality support for qualification & validation approval for IT infrastructure & major system projects.
  • Assures installation, qualification & validation of IT systems to meet objectives & requirements including risk assessment.
  • Participate in internal & external audits of IT vendors & systems for compliance to regulatory & Novo Nordisk requirements.
  • Interprets relevant regulations & procedures to apply to systems & processes.
  • Participate in continuous improvement projects & initiatives on IT-related systems & projects.
  • Serve as the Quality representative for IT-related activities, maintaining compliance of IT systems during validation, remediation, nonconformities & project-related activities.
  • Responsible for maintaining compliance for IT-focused site documentation (e.g. local procedures & change control documentation).
  • Follow all safety & environmental requirements in the performance of duties.
  • Problem solving with team & stakeholders while maintaining compliance to requirements
  • Operates in alignment with NNWay, demonstrating a Quality & cLEAN Mindset.
  • Other accountabilities, as assigned.

Required Qualifications:
  • BA/BS in IT, CIS, MIS, Engineering or other technical science field
  • Minimum of three (3) years of combined IT & quality experience in manufacturing, utility, and/or packaging systems, preferably in the pharmaceutical or medical device field.
  • Experienced with regulatory requirements & industry standards for pharmaceutical and/or medical device manufacture, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration items lists, FDA guidance documents & ICH guidance documents.
  • Experienced in the development, implementation, validation, and/or maintenance of IT systems in the pharmaceutical/medical device manufacturing, laboratory, or business environment.
  • Proven experience with quality systems, preferably in pharmaceutical industry.
  • Strong Quality Assurance skills with experience in computer system validation in GxP environments.
  • Experience with IT validation software.
  • Excellent organization & communication skills.

Desired Qualifications:
  • Knowledge of FDA regulations & guidelines as they relate to computer-based information systems.
  • Experience in pharmaceutical manufacturing preferred.
  • Excellent troubleshooting skills; can identify root cause of a problem & assist in determining appropriate IT or technical solutions.
  • Knowledgeable in PLC, SCADA, Virtualization/Storage, Active Directory, MES/LMES (Oracle), and/or MS SQL.
  • Demonstrated leadership & project management skills: two-way communication skills with customers (internal/external), project team & management; interpersonal & team building skills; achievement of project timelines & customer requirements; Quality mindset.
  • Familiar with LEAN, Six Sigma & continuous improvement methodologies.
  • IT audit experience desirable.

Physical Requirements:
  • Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions.
  • Constantly operates a computer & other office equipment using hands.
  • Able to travel internationally, up to 15% of the time.
  • Able to work in an open office environment with the possibility of frequent distraction.
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation.

Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

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.

Requisition ID: 60215BR
State/Provinces: Clayton
Job Category: Quality

Basic Qualifications