Company DescriptionGerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.Gerresheimer Peachtree City L.P. was established in 1993 in Peachtree City, GA, as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry. The subsidiary operates in an 87,500 sq. ft. production facility with 200 employees. Job DescriptionIndependent planning, coordination and implementation of necessary qualification and validation activities related to all production and support processes including corresponding documentationValidation activities during the projects including evaluation of test results and change/deviation management (e.g. for Production equipment, systems, software, peripherals, buildings and facilities etc.)Monitoring of the required quality activities around the Validation activities (e.g. ordering test equipment, material qualification, supplier matters)Creation of corresponding documentation according to the work instructionsSupport and, if necessary, organization of risk management activities within the projectsChanges evaluation in terms of their impact on the qualified/validated stateCarry out requalification activitiesCreation of customer declarations etc. (possibly in cooperation with others positions e.g. Regulatory Affairs)Create and maintain test/sample setsSupport for internal audits, customer audits and if needed supplier auditContribution to new procedures, procedure updates and improvements (process descriptions work instructions)QualificationsKnowledge as typically acquired during at least 3 years of technical university studies (e.g. mechanical engineering, industrial engineering, or similar) and extended by at least 5 years of relevant professional experience in the areas of quality assurance, qualification and/or validation.This function requires special knowledge in the areas of verification and validation of processes & qualification of equipment.1-2 years of experience using project management methods1-2 years of using statistical QM methods1-2 years of experience working with IT applications (e.g. Office programs, MES, QM system)Knowledge of quality management, QM methods and QM guidelinesKnowledge of problem-solving methods (e.g. KT)Good technical understanding in dealing with specificationsExcellent analytical competence (especially in the field of interpretation of results and derivation of further measures)Fluent in EnglishAdditional InformationMon - Fri / 40hrscompany health benefits, 401k, incentive bonusesAll your information will be kept confidential according to EEO guidelines.