Quality Engineer Sterile Products

About usHuman health matters. SCHOTT Pharma designs science-based solutions to ensure medications are safe and easy to use globally. A team of 4,700 people from over 60 nations contributes to global healthcare. With 17 sites worldwide, the company is headquartered in Mainz, Germany, listed on the Frankfurt Stock Exchange, and committed to sustainable development for society and the environment.Your ContributionValidation and re-validation of sterilization processesLead regional or customer led improvement activities and support applicable rolloutsPerform trending and monitoring of relevant quality KPIs pertaining to Sterile products and related quality aspects; implement improvement measures accordinglyAssure compliance with ISO certifications (ISO 9001, ISO 15378) and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelinesSupport the laboratory side of engineering through method and equipment validation/qualification initiativesManage and trend data from EM process, raw materials and finished product testing reltated to Sterile productsPerform site based risk assessmentsLead process mapping and continuous improvement activities using Lean principles and toolsMonitor and support the proper implementation of change controlsSupport quality control plan analysis and improvements, including packaging development and execution of related projects and action itemsCoordinate, collect and analyze quality data for customers; troubleshoot and resolve customer issues; provide root cause analysis and corrective/preventative actions to eliminate reoccurrencesManage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventative and corrective actions in a timely manner resulting from customer complaints, internal or customer audit findingsSupport experimental and validation protocols for equipment, processes and materials, while designing protocols, performing tests and completing technical reportsDevelop and document best practice methods; ensure standardized proceduresParticipate in required trainings and meetings, when necessaryHelp promote and implement safety/EHS directives and maintain a clean and safe workspaceYour ProfileBachelor’s Degree in Chemistry, Microbiology, or related field, requiredMinimum (5) years of experience within a Quality Engineer role with sterile productsMinimum (3) years of experience in product/process investigations, validations, instrument qualifications and EM programsSolid knowledge of ISO 9001, 13485 and 15378, along with cGMP, preferredExperience in glass forming industry and/or pharmaceutical industry, preferredSound computer knowledge and skills including MS Office, SAP and MinitabMulti-tasking abilities and prioritizationDetail oriented approach; service orientedDecision making skillsForward and creative thinkingAnalytical/critical thinkingEffective communication skillsAbility to read, write and speak English languageYour BenefitsExcellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon electionPlease feel free to contact us