Senior Packaging Engineer, Consultant

Apply Location Irvine, CA Full Remote Posted Sep 9, 2026 Position Overview We are seeking an experienced Senior Packaging Engineer Consultant to provide project-based packaging expertise, leadership, and oversight for our client’s Contract Manufacturing Organization (CMO) in Switzerland. This is a remote consulting opportunity; travel to Switzerland is not required. The consultant will serve as the primary packaging subject matter expert (SME), overseeing the planning, design review and development, procurement, qualification, and execution of packaging activities at the CMO. The successful candidate will work closely with the CMO and internal project stakeholders to ensure packaging activities are appropriately planned, technically sound, compliant with applicable regulatory requirements, and executed according to project timelines and quality expectations. Key Responsibilities Provide overall packaging SME leadership and technical oversight including planning and execution of primary and secondary packaging activities, such as:Single-unit punch-out processes for separating individual BFS vialsActive and buffer unit foil pouchingSecondary packaging activities, including: CartoningIFU (Instructions for Use) insertionTE seal applicationOther packaging operations as required by the projectProvide SME support for the identification, selection, and procurement of packaging equipment required for the projectProvide expert oversight of packaging equipment specifications, vendor interactions, installation, and readiness, as appropriateProvide overall vendor oversight and packaging-related support, ensuring vendors and the CMO remain aligned with project requirements, timelines, quality expectations, and technical standardsReview packaging designs, processes, specifications, procedures, and documentation as neededIdentify potential packaging risks, technical issues, and project constraints and provide recommendations and mitigation strategiesSupport packaging-related investigations, deviations, change controls, and problem-solving activities, as neededProvide technical input and support for regulatory filings and regulatory responses related to packaging activities, as requiredParticipate in project meetings, design reviews, technical discussions, and CMO/vendor meetings as the packaging SMEEnsure packaging activities are appropriately documented and aligned with applicable GMP, quality, regulatory, and company requirementsProvide expert guidance to the CMO as it plans and executes packaging activities through project milestones and commercial/clinical readiness, as applicable Qualifications & Experience Bachelor's degree plus 10 years of relevant packaging engineering or pharmaceutical packaging experience, with significant experience in a senior or SME capacityDemonstrated experience overseeing packaging activities at a CMO/CDMOStrong knowledge of pharmaceutical packaging processes, equipment, and packaging operationsExperience with BFS vial packaging and/or comparable unit-dose pharmaceutical packaging processes strongly preferredExperience with foil pouching, cartoning, IFU insertion, sealing, and other secondary packaging operationsExperience supporting the selection and procurement of packaging equipment and working with equipment suppliers/vendorsStrong understanding of GMP, quality systems, and regulatory expectations related to pharmaceutical packagingDemonstrated ability to manage external vendors and CMO relationships from a technical and project oversight perspectiveAbility to provide clear technical direction and make sound recommendations while operating in a consulting/oversight capacity Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Apply Key Responsibilities Provide overall packaging SME leadership and technical oversight including planning and execution of primary and secondary packaging activities, such as:Single-unit punch-out processes for separating individual BFS vialsActive and buffer unit foil pouchingSecondary packaging activities, including: CartoningIFU (Instructions for Use) insertionTE seal applicationOther packaging operations as required by the projectProvide SME support for the identification, selection, and procurement of packaging equipment required for the projectProvide expert oversight of packaging equipment specifications, vendor interactions, installation, and readiness, as appropriateProvide overall vendor oversight and packaging-related support, ensuring vendors and the CMO remain aligned with project requirements, timelines, quality expectations, and technical standardsReview packaging designs, processes, specifications, procedures, and documentation as neededIdentify potential packaging risks, technical issues, and project constraints and provide recommendations and mitigation strategiesSupport packaging-related investigations, deviations, change controls, and problem-solving activities, as neededProvide technical input and support for regulatory filings and regulatory responses related to packaging activities, as requiredParticipate in project meetings, design reviews, technical discussions, and CMO/vendor meetings as the packaging SMEEnsure packaging activities are appropriately documented and aligned with applicable GMP, quality, regulatory, and company requirementsProvide expert guidance to the CMO as it plans and executes packaging activities through project milestones and commercial/clinical readiness, as applicable Qualifications & Experience Bachelor's degree plus 10 years of relevant packaging engineering or pharmaceutical packaging experience, with significant experience in a senior or SME capacityDemonstrated experience overseeing packaging activities at a CMO/CDMOStrong knowledge of pharmaceutical packaging processes, equipment, and packaging operationsExperience with BFS vial packaging and/or comparable unit-dose pharmaceutical packaging processes strongly preferredExperience with foil pouching, cartoning, IFU insertion, sealing, and other secondary packaging operationsExperience supporting the selection and procurement of packaging equipment and working with equipment suppliers/vendorsStrong understanding of GMP, quality systems, and regulatory expectations related to pharmaceutical packagingDemonstrated ability to manage external vendors and CMO relationships from a technical and project oversight perspectiveAbility to provide clear technical direction and make sound recommendations while operating in a consulting/oversight capacity Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.