3 jobs found in michigan

ROLE SUMMARY This position provides technical expertise and operational support for the design, installation, start up, and routine operation of new aseptic filling equipment within the B41 Injectables operation.   Partners with shop floor colleagues and supervision to ensure completion of appropriate start up and qualification activities, including assistance with equipment troubleshooting as needed.  Key accountabilities include ensuring all equipment functions as intended to successfully manufacture drug products on schedule, and all product is produced in a manner meeting safety and quality requirements.      ROLE RESPONSIBILITIES Develops and validates manufacturing  equipment and processes for drug products, taking into consideration problems inherent in the transfer of technology from research to production, from other sites, or within the site. Leads Operational team in the review and approval of associated...

ROLE SUMMARY This position is for a Subject Matter Expert (SME) for Lyophilization (also referred to as Freeze Dry or Lyo) operations.  The scope of the role includes support of Lyophilization related capital projects and operational support of existing Lyophilization operations.  Key accountabilities include ensuring that the existing lyophilizers are functioning at an optimal state and that all new lyophilizers or modified lyophilizers function as intended to successfully manufacture drug products on schedule, ensuring all product is produced in a manner meeting safety and quality requirements.   ROLE RESPONSIBILITIES Serves as subject matter expert on lyophilizer and/or automated loading/unloading systems.  As responsible person for functionality of the lyophilization equipment, interfaces closely with operators, freeze dry leadership, maintenance, and quality to ensure the lyophilizers are functioning as intended. Leads technical...

ROLE SUMMARY   Process Technologist will function as a member of the Process Centric Team (PCT) to provide technical expertise and operational support. This role will also report to the Reliability Team. The role owns and facilitates the implementation and management of the Total Productive Maintenance (TPM) program; operator care, work management and reliability based maintenance. The role owns & facilitates the IMEx ecosystem element accountable for the equipment/asset care processes, which will impact the OEE of manufacturing processes. The role will leverage coaching and training of operators to enhance equipment understanding, perform effective root cause analysis, and drive equipment performance improvements. The role partners with other PCT members, shop floor colleagues, and supervision to enhance equipment understanding towards a consistent and efficient operation. Responsibilities or influence may extend to additional PCTs.   ROLE...