Packaging Engineer

pOur client is seeking an experienced bPackaging Engineer /b to support commercial pharmaceutical packaging operations across a global product portfolio. This role will serve as a key packaging SME, managing packaging engineering activities with external CMOs and ensuring compliance, quality, and uninterrupted product supply. The successful candidate will play a critical role in packaging lifecycle management, change implementation, qualification activities, and documentation governance within a highly regulated GMP environment. /p h3Responsibilities: /h3 ul liManage packaging engineering activities at external CMOs, including oversight of packaging-related documentation and compliance requirements. /li liLead and support the development, launch, lifecycle management, and continuous improvement of primary and secondary packaging components. /li liCoordinate the qualification and implementation of new packaging components, materials, suppliers, and manufacturing processes to ensure supply continuity and risk mitigation. /li liDevelop, review, and approve technical drawings, packaging specifications, profiles, and purchasing/release documentation. /li liExecute and support packaging process validation and qualification activities on packaging equipment. /li liOwn and manage change controls, deviations, non-conformances, investigations, and CAPAs in collaboration with Quality, Regulatory, and cross-functional stakeholders. /li liMaintain and update Bills of Materials (BOMs) and packaging master data. /li liDrive harmonization and standardization initiatives for platform packaging components across multiple markets. /li liEnsure packaging solutions meet regulatory requirements, including serialization, authentication, and global labeling standards. /li liCollaborate closely with internal teams and external technical experts across multiple regions and time zones to deliver projects on time and in compliance. /li /ul h3Must-Haves: /h3 ul liBachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, or a related engineering discipline. /li liMinimumb 5 years of experience /b in pharmaceutical, biotech, or other highly regulated manufacturing environments. /li liStrong knowledge of bcGMP requirements /b and pharmaceutical packaging documentation standards. /li liHands-on experience with quality management systems, particularly bTrackWise /b (mandatory); familiarity with Veeva is an advantage. /li liProven experience qualifying packaging components and packaging equipment. /li liExperience creating, reviewing, and approving technical specifications, profile drawings, and packaging documentation. /li liSolid understanding of packaging process validation and lifecycle management. /li liDemonstrated experience managing change controls, deviations, investigations, and CAPAs. /li /ul #J-18808-Ljbffr