Sr Qualification Engineer in Lincoln, NE

Job ID95010BRPosting TitleSr Qualification EngineerDivisionOver The CounterBusiness UnitOver The CounterCountryUSAWork LocationLincoln, NECompany/Legal EntityUSA Novartis Consumer Health, Inc., Parsippany, NJFunctional AreaProductionJob TypeFull TimeEmployment TypePermanentJob DescriptionThe Senior Qualification Engineer is responsible to prepare, review and approve qualiication protocols and reports for equipment, facilities, systems and procedures for GMP equipment; provide technical support on project teams, investigations and in the review and approval of change controls; audit all qualification documentation for compliance with current corporate, FDA and regulatory qualifications. The Senior Qualification Enineer leads large proejcts and is capable of managing small technical teams.Major Accountabilities? Maintain qualification documentation to ensure compliance for all site systems and processes. ? Develop and execute user and functional qualifications, system designs, IQ/QQ/PQ protocols and summary reports for pharmaceutical products.? Prepare qualification or performance qualification protocols for new or modified processes, systems and equipment.? Analyst qualification test data to determine whether systems or processes have met qualification criteria or to identify root causes of production problems.? Coordinate the implementation or scheduling of qualification testing with affected departments and partners.? Prepare, maintain or review qualification and compliance documentations, such as engineering change notices, schematics, protocols, etc. ? Resolve testing problems by modifying testing methods or revising testing objectives and standards.? Prepare detailed reports to design statements based on results of qualification and qualification tests or reviews of procedures and protocols.? Manage small technical teams.? Maintain ability and working understanding of the most recent expectations of Novartis quality and external regulatory parties.? Know, understand, and follow all applicable health, safety & environmental policies and pro-cedures.? Promote a strong safety culture by modeling safe behaviors and holding self and others air conditioner-countable for working safely.Min requirementsBS degree in mechanical engineering, industrial pharmacy, chemistry, or other appropriate scientific, pharmaceutical or engineering discipline.At least 7yrs of demonstrated background in equipment qualiication, automation, quality and compliance areas in a pharmaceutical or related industry.Only online applications will be considered. Please contact ([removed phone] if you require accommodation under the American's with Disabilities Act to apply for this position.Listing originally posted at http