Quality Engineer
About the CompanyReports To Quality Director of OperationsAbout the RoleThe Quality Engineer – Sterile Compounding is responsible for maintaining and improving the Quality Management System (QMS) within a 503A sterile compounding pharmacy in compliance with USP, FDA expectations, and applicable state regulations. This role expands beyond traditional QA Specialist responsibilities to include equipment qualification (IQ/OQ/PQ), process validation, environmental control strategy, and continuous process improvement. The Quality Engineer ensures that sterile compounding operations are scientifically controlled, validated, and inspection-ready at all times.ResponsibilitiesSupport and maintain elements of the Quality Management System (QMS)Author, revise, and execute technical operations (IQ/OQ/PQ) protocols, and technical reportsEnsure USP procedures are scientifically sound and effectively implementedLead deviation, investigation, and CAPA processes with a risk-based approachPerform quality risk assessments (FMEA, risk ranking, etc.)Analyze and trend quality data (EM, deviations, complaints, audit findings)Support internal audits, gap assessments, and regulatory inspections (FDA, State Boards)Lead and execute equipment qualification lifecycle:Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Develop and approve qualification protocols and reports for:Cleanroom HVAC systems with HEPA filtration systemsLaminar airflow workbenches (LAFW), BSCs (Biological Safety Cabinets)Temperature mappingsCritical compounding equipment (autoclave and oven)Ensure calibration and preventive maintenance programs are effectiveSupport cleanroom certification reviews and requalification activitiesDesign and execute process validation strategies for sterile compoundingLead aseptic process simulations (media fills) and requalification programsDevelop validation protocols including:Worst-case conditionsProcess challenge studiesHold time studiesEvaluate process capability and variabilityEnsure validated state is maintained through lifecycle monitoringOversee viable and non-viable environmental monitoring programPerform trend analysis and statistical evaluation of EM dataEstablish alert/action levels and contamination control strategiesLead investigations into EM excursions and implement corrective actionsSupport contamination control strategy (CCS) aligned with USPLead root cause investigations using structured methodologies (5 Whys, Fishbone, etc.)Develop and implement effective CAPAsMonitor CAPA effectiveness and closure timelinesIdentify process improvement opportunities using data and trendsDrive continuous improvement initiatives across sterile operationsEnsure personnel qualification programs are compliant and effective:Aseptic technique qualificationMedia fill certificationGowning qualificationVisual inspection and labeling qualification programSupport development of training materials and technical instructionEvaluate operator performance and requalification needsReview and approve Certificates of Analysis (COAs)Support supplier qualification and risk assessmentEnsure incoming materials meet sterile compounding requirementsParticipate in vendor audits and quality agreementsQualifications - RequiredBachelor’s degree in Engineering, Life Sciences, or related field5+ years experience in sterile compounding, pharmaceutical quality, or regulated environmentStrong knowledge of USP and aseptic processing principlesExperience with equipment qualification (IQ/OQ/PQ) and/or process validationKnowledge of quality systems, investigations, and CAPAQualifications – PreferredExperience in GMP regulated industry and/or aseptic sterile operationsFamiliarity with USPExperience with cleanroom design and contamination control strategyExposure to FDA inspections or regulatory auditsLean/Six Sigma or quality certification (ASQ CQE, CQA, etc.)Skills & CompetenciesStrong technical writing (protocols, reports, investigations)Analytical thinking and problem-solving capabilityAbility to interpret data and apply statistical toolsAttention to detail with strong compliance mindsetCross-functional collaboration and communicationProficiency in Excel and quality management systemsWorking ConditionsWork in ISO-classified cleanroom environmentsRequired gowning and aseptic practicesCombination of desk-based analysis and floor supportOccasional lifting and standing in controlled environmentsKey Performance Indicators (KPIs)Equipment qualification on-time completion (IQ/OQ/PQ)Process validation success and state of controlEnvironmental monitoring trend performanceDeviation and CAPA closure effectivenessInspection readiness and audit outcomesTraining and qualification compliance rates