Validation Area Specialist - Production Support

Novo Nordisk Clayton , NC 27527

Posted 3 months ago

Job description:

Job description

Location

Clayton, United States

Job category

Quality

Apply now

About the Department

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. Working at our Diabetes Active Pharmaceutical Ingredient (DAPI) manufacturing facility you will help meet the growing demand for our treatments. Novo Nordisk expects to double production of diabetes and obesity drugs over the next decade and are currently building a new 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC next to our existing "fill and finish" manufacturing facility. Our new $2 billion API facility is expected to be operational in 2020, with 700 full-time employees responsible for the fermentation, recovery and purification of insulin and GLP1 ingredients. This once in a life-time career opportunity is ideal for pharmaceutical manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us build, validate, and run our processes. Here, you will work with the best manufacturing professionals in the industry. Are you ready to make a difference?

Position Purpose

Perform Commissioning, Validation & Periodic System Evaluations (PSE) on equipment/processes per approved timelines. Support production engineers in writing change requests, deviation investigation & writing. Support validation activities associated with changes to existing & new systems. Processes include purified water systems, nitrogen and process air, miscellaneous solvents.

Accountabilities

  • 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 &/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 NNWay, demonstrating a Quality & cLEAN Mindset

  • Other accountabilities, as assigned

Required Qualifications

  • BA/BS in Engineering/pharmaceutical sciences, or equivalent years of relevant experience in Validation & Good Manufacturing Practice (GMP) documentation

  • Minimum of two (2) years of validation related discipline experience in pharmaceutical or medical device industry

Desired Qualifications

  • Experience in quality concepts including technical & compliance review of validation & quality documents

  • Experience in one or more core validation areas (equipment, clean & black utilities)

  • 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. Experience with working with Quality Control & tracking testing requirements

  • Minimum of one (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

At this time, 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.

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Validation Area Specialist - Production Support

Novo Nordisk