Senior Quality Engineer

Key ResponsibilitiesProvide quality oversight for pharmaceutical packaging, labeling, and serialization operationsSupport automated and high-speed packaging line activities within a GMP environmentManage investigations, deviations, CAPAs, and change controls related to packaging and labeling eventsReview and approve SOPs, batch record documentation, and packaging specificationsSupport validation and qualification activities for packaging equipment and labeling systemsPartner cross-functionally with Manufacturing, Engineering, Technical Services, and Supply Chain teamsEnsure inspection readiness for FDA, EMA, and client auditsSupport defect investigations, label reconciliation, and packaging compliance initiativesDrive continuous improvement efforts across packaging quality systemsMaintain compliance with serialization and track-and-trace requirementsQualifications5+ years of experience in pharmaceutical or biotech Quality AssuranceDirect experience supporting packaging, labeling, or serialization operations in a GMP-regulated environmentExperience within sterile injectable, biologics, or other highly regulated manufacturing environments preferredStrong understanding of deviations, CAPAs, risk assessments, and validation activitiesFamiliarity with automated packaging technologies and serialization platformsExperience supporting FDA and/or EMA inspectionsStrong communication skills with the ability to work across multiple departments