Job Description Our Company`s Schachen site serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them. The Biotech facility, at Schachen, state‑of‑the‑art facility that enables and advances our best work. By integrating leading‑edge technology with a dynamic, activity‑based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline. Materials and Cleaning Validation Senior Specialist is responsible for supporting the cleaning validation and Single Use Technology activities, ensuring compliance with internal standards, regulatory requirements, and industry best practices. The role contributes to the development, execution, and maintenance of validation documentation, technical assessments, and risk‑based solutions, while supporting the introduction of new products, equipment, and processes. Working closely with cross‑functional partners, the Senior Specialist helps maintain robust, reliable, and efficient manufacturing operations. Cleaning Validation and Sterilization Lead the site cleaning validation program and support the development, update, and execution of cleaning validation documentation, including protocols, reports, studies, and risk assessments. Design and improve cleaning procedures for new products, new equipment, and manufacturing processes, including clean‑in‑place practices where applicable. Support timely introduction of NPI and new equipment into the validation program through technical assessment, planning, and execution. Review and approve cleaning‑related working instructions, forms, and change controls. Investigate cleaning‑related incidents, deviations, and out‑of‑specification results, including root cause analysis and troubleshooting. Support periodic review of cleaning validation studies and ensure timely resolution and closure of cleaning‑related incidents and deviations. Train manufacturing, QC, and QA personnel on cleaning validation documentation, procedures, and compliance requirements. Prepare for and support internal and external audits and inspections related to cleaning validation. Single Use Technology Contribute to the development and execution of the site Single Use Technology strategy in close collaboration with Technology
Kontaktdaten:
Merck Gruppe - MSD Sharp & Dohme Recruiting-Team
