Process Validation Engineer in Lincoln, NE

Job ID93926BRPosting TitleProcess Validation EngineerDivisionOver The CounterBusiness UnitOver The CounterCountryUSAWork LocationLincoln, NECompany/Legal EntityUSA Novartis Consumer Health, Inc., Parsippany, NJFunctional AreaProductionJob TypeFull TimeEmployment TypePermanentJob DescriptionThe Lincoln, Nebraska manufacturing facility of global pharmaceutical leader Novartis Consumer Health, producer of EXCEDRIN, THERAFLU, TRIAMINIC and other familiar over-the-counter brands, is seeking a Process Validation Engineer to lead, coordinate, execute, and summarize process validation and cleaning validation activities.RESPONSIBILITIES? Write and review process validation (PV) study documentation, protocols and reports.? Write and review cleaning validation (CV) study documentation, protocols and reports.? Execute and document study results for process validation protocols and cleaning validation protocols.? Lead assigned process validation and cleaning validation studies. Coordinate and communicate with stakeholders to ensure accurately and timely completion of the studies.? Document sampling, perform testing, and document test results throughout the stages of production / unit operations as required by PV or CV protocols.? Conduct peer review of protocols and reports.? Conduct periodic review of equipment/utilities qualification documentation.? Write and review Engineering Studies or other protocols as required.? Train manufacturing, laboratory, and other stakeholder groups on process and cleaning validation protocols and Formula Manufacturing Records (FMRs) related to PV or CV studies and PV or CV program procedures as required.? Train/mentor less experienced teammates.Min requirementsBS and 4 yrs of related skills in Pharmaceutical or related industry - or - MS and two years of related skills in Pharmaceutical or related industry - or - PhD and no significant background.Only online resumes will be accepted. If you require accommodation under the Amercian's with Disabilities Act to apply for this position, please contact Suzanne Drew at ([removed phone].Listing originally posted at http