Validation Area Specialist - AP Job:
Novo Nordisk

Novo Nordisk
Clayton North Carolina
Position Purpose:

Perform Revalidation & Periodic System Evaluations (PSE) on equipment/processes per approved timelines. Support validation activities associated with changes to existing & new systems. Processes include formulation, sterilization, cleaning, filling & inspection.

  • Perform, review & approve revalidation & PSE activities. Must be able to work & communicate effectively across multiple departments to schedule & perform revalidation & PSE assignments.
  • Review & approve documents in accordance with local, corporate & regulatory regulations.
  • Collaborate, review & approve IQ, OQ & PQ protocols for systems/processes per approved timeframes.
  • Support and/or lead the closure of investigations per approved timeframes using root cause analysis techniques. Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures.
  • Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria.
  • Responsible for Change Requests (CR’s) related to revalidation & other validation activities for AP.
  • Review & approve validation procedures, specifications & quality documents for accuracy & compliance.
  • Presentation & support for validation concepts & approaches with audits & inspections.
  • Follow all safety & environmental requirements in the performance of duties.
  • Operate in alignment with Novo Nordisk Way, demonstrating a Quality & cLEAN® Mindset.
  • Other accountabilities, as assigned.

Required Education:

BS in Engineering, Computer Science, or applicable scientific or technical degree.

Required Experience:

2+ years validation related discipline experience in pharmaceutical or medical device industry.

Technical/Process/Functional Knowledge:
  • Experience in quality concepts including technical & compliance review of validation & quality documents.
  • Experience in one or more core validation areas (sterilization, cleaning, process or computer validation).
  • Experience in cGMP documentation practices & regulations.
  • Basic computer skills including experience in the use of Microsoft word, Excel, etc.
  • Knowledge of statistical methods.
  • Strong oral & written communication skills.
  • Experience with validation test equipment including temperature mapping equipment (for example: Kaye Validator), desired.
  • Experience in project team collaboration & support.
  • At least 1 year of demonstrated experience using root-cause analysis techniques to solve problems.

Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams.

Physical & Other 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 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.
  • Able to adjust schedule to work with colleagues in other international time zones.

Requisition ID: 59651BR
State/Provinces: Clayton
Job Category: manufacturing

Basic Qualifications