Quality Process Engineer

u003cdiv id= '07d76e7ef19542f9 ' class= 'conversation-container message-actions-hover-boundary ng-star-inserted 'u003eu003cdiv class= 'response-container ng-tns-c2003732650-18 response-container-with-gpi ng-star-inserted 'u003eu003cdiv class= 'presented-response-container ng-tns-c2003732650-18 'u003eu003cdiv class= 'response-container-content ng-tns-c2003732650-18 'u003eu003cdiv class= 'response-content ng-tns-c2003732650-18 'u003eu003cdiv id= 'model-response-message-contentr07d76e7ef19542f9 ' class= 'markdown markdown-main-panel tutor-markdown-rendering enable-updated-hr-color ' dir= 'ltr 'u003eu003ch2u003eQuality Process Engineeru003c/h2u003eu003cpu003eSanford, Maineu0026 u003c/pu003eu003cpu003e80-115K + Bonus + Full Benefitsu0026 u003c/pu003eu003ch3u003eu003cstrongu003eJob Summaryu003c/strongu003eu003c/h3u003eu003cpu003eThe u003cstrongu003eQuality Process Engineeru003c/strongu003e acts as a critical link between u003cstrongu003eInnovation/Technical Developmentu003c/strongu003e teams and u003cstrongu003ePlant Operations/Quality Assuranceu003c/strongu003e. This role is responsible for driving plant quality performance and continuous consumer satisfaction through meticulous process optimization, robust technical transfer, and comprehensive validation leadership in a regulated manufacturing environment. The successful candidate must thrive in an energetic, fast-paced setting while maintaining strict attention to detail and promoting effective internal and external networking.u003c/pu003eu003ch3u003eu003cstrongu003eKey Responsibilitiesu003c/strongu003eu003c/h3u003eu003culu003eu003cliu003eu003cpu003eu003cstrongu003eProcess Validation u0026Quality Compliance Leadership:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eu003cpu003eOversee and manage the u003cstrongu003esite validation programu003c/strongu003e, including u003cstrongu003eCleaning and Sanitization (Cu0026S) validationu003c/strongu003e plan leadership and execution.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eConduct risk analysis, maintain and update the u003cstrongu003eValidation Master Planu003c/strongu003e, and develop u003cstrongu003ePerformance Qualification (PQ) protocolsu003c/strongu003e, supporting IQ/OQ in partnership with the Engineering team.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eEnsure compliance with quality standards, including u003cstrongu003ecGMPu003c/strongu003e and u003cstrongu003e21 CFR 210 u0026211u003c/strongu003e.u003c/pu003eu003c/liu003eu003c/ulu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eTechnical Transfer u0026System Management:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eu003cpu003eLead the u003cstrongu003eTechnology Transfer Quality Standardu003c/strongu003e application specific to site activities.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eManage u003cstrongu003eSAP item setupu003c/strongu003e and ensure accountability for the u003cstrongu003eManagement of Change (MOC)u003c/strongu003e process.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eLead the creation, optimization, and management of u003cstrongu003eInbatch recipesu003c/strongu003e.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eConduct technical reviews of changes in specifications, processes, formulas, packaging, and labeling to ensure product quality.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eEnsure site quality systems are configured for current and upcoming production requirements in a timely manner.u003c/pu003eu003c/liu003eu003c/ulu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eOperations Support u0026Continuous Improvement:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eu003cpu003eProvide daily on-the-floor support to address quality issues and continuous improvement initiatives, actively participating in site Standard Daily Meetings (SDM) and Internal Quality Area Meetings.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eUtilize quality tools such as u003cstrongu003eChange Control, Failure Investigation, Control Charts, Corrective u0026Preventive Actions (CAPA)u003c/strongu003e, and u003cstrongu003eNotice of Deviationsu003c/strongu003e to drive continuous improvement.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eLead product inspections, line trials, and other Quality Key Performance Indicator (KPI) activities.u003c/pu003eu003c/liu003eu003c/ulu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eCross-Functional Partnership u0026Training:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eu003cpu003eInterface effectively with key business partners including Operations, Technology, Procurement, and Vendors.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eConduct training sessions on topics like u003cstrongu003eGMP, quality standards, and validationu003c/strongu003e.u003c/pu003eu003c/liu003eu003c/ulu003eu003c/liu003eu003c/ulu003eu003ch3u003eu003cstrongu003eRequired Qualificationsu003c/strongu003eu003c/h3u003eu003culu003eu003cliu003eu003cpu003eu003cstrongu003eEducation:u003c/strongu003e Bachelor's degree in Chemical / Mechanical Engineering, Chemistry, or a related science/engineering discipline.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eExperience:u003c/strongu003e A minimum of u003cstrongu003e2-3 yearsu003c/strongu003e of experience in manufacturing, a quality role, or equivalent. (Mid-Senior level experience preferred).u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eSkills:u003c/strongu003e Demonstrated u003cstrongu003eproject management skillsu003c/strongu003e and the ability to communicate effectively and deliver results in a fast-paced work environment.u003c/pu003eu003c/liu003eu003c/ulu003eu003ch3u003eu003cstrongu003ePreferred Qualificationsu003c/strongu003eu003c/h3u003eu003culu003eu003cliu003eu003cpu003eA strong background in u003cstrongu003equality systems, process validationu003c/strongu003e, and a thorough understanding of u003cstrongu003ecGMPu003c/strongu003e and u003cstrongu003e21 CFR 210 u0026211u003c/strongu003e.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003ePrior experience working in a u003cstrongu003eregulated industryu003c/strongu003e (e.g., FDA-regulated).u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eWorking knowledge of u003cstrongu003eSAPu003c/strongu003e, validation software (e.g., KNEAT), u003cstrongu003eInBatchu003c/strongu003e, or similar plant/quality-related computer systems.u003c/pu003eu003c/liu003eu003c/ulu003eu003c/divu003eu003c/divu003eu003c/divu003eu003c/divu003eu003c/divu003eu003c/divu003e ', 'location ': 'Sanford, ME ', 'remote ':null, 'jobtype ': 'directhire ', 'remoteoption ': 'notspecified ', 'featuredonjobboard ':false, 'ownedbyagency ':false, 'externalid ': 'CA168-2749766

Created: 2025-11-15