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Are you a detail-oriented professional with a passion for pharmaceutical excellence? Join the J&J Innovative Medicine MSAT Large Molecule Drug Product team and play a pivotal role in ensuring the quality and compliance of primary packaging materials. This is your chance to manage critical lifecycles within a world-class manufacturing environment, driving innovation and stability in primary container systems. As a Lifecycle Management Specialist, you will act as a key technical anchor for the Primary Container team. Your primary mission is to oversee and execute Change Controls triggered by supplier notifications, ensuring that every material in the portfolio meets the highest quality standards. You will bridge the gap between technical specifications and operational excellence, ensuring seamless processability for our drug products.
Job Responsibility:
Change Control Leadership: Lead and manage all change controls associated with supplier notifications for primary packaging materials, including the preparation of all required deliverables
Technical Specification Review: Critically evaluate supplier specifications to ensure total alignment with own quality standards
Reporting & Analysis: Author comprehensive comparability reports to assess the processability of primary packaging materials
Activity Coordination: Oversee all functional and technical testing activities related to Change Control processes
Requirements:
Experience: Generally requires 4–6 years of relevant work experience
Background: Proven experience in Pharmaceutical operations or manufacturing environments
Subject Matter Expertise: Deep knowledge of primary packaging materials and parenteral production processes
Soft Skills: Strong analytical and project management skills with a meticulous eye for detail
Communication: Fluent in English
Technical Proficiency: Skilled in SAP, Comet software, Minitab, Excel, and PowerPoint