Catalent, Inc.
Contract Development and Manufacturing Organization (CDMO)
ManufacturingSciencesandTechnology(MS&T)EngineerIII
“Manufacturing Sciences and Technology (MS&T) Engineer III at Catalent, Inc.. Skills: MS&T, technical process development, technology transfer, cGMP, documentation, project coordination, cross-functional collaboration, deviation management, change control management, CAPA management. manage and execute assigned projects. support technology transfer for both internal and external processes”
What You'll Achieve.
ensure processes are successfully transferred and maintained in compliance with cGMP and change control requirements; ensure process consistency; drive successful adherence and completion of projects
Industry & Context.
troubleshoot issues; drive corrective actions; risk assessments (FMEA, Hazard Analysis); process improvements; determination of event impact; root-cause analysis; corrective action identification
100% on-site (San Diego), able to perform duties which include standing, walking, sitting, kneeling, push/pulling frequently and significant amount of use of office, able to lift up to 35lbs, work in temperature-controlled freezers/fridges occasionally
What They're Looking For.
Must Have
Minimum of 3 years of experience in a customer service or appropriate business-related area, Experience writing SOPs, batch records, and technical leading cross‑functional method development, qualification, and tech transfer and executing investigations, deviations, and change controls with a right‑first‑time mindset required, Demonstrated ability to analyze and interpret data, perform peer reviews, identify trends, troubleshoot issues, and drive corrective actions, risk assessments (FMEA, Hazard Analysis), and process improvements
Nice to Have
Minimum of 5 years of experience with GMP equipment, manufacturing, healthcare, and/or pharmaceutical preferred, Project management experience and skills preferred, Artios CAD experience preferred
What You'll Do.
manage and execute assigned projects
support technology transfer for both internal and external processes
maintain accurate technical documentation
coordinate projects ensuring correct technical requirements documentation generated
monitored and drive successful adherence and completion
communicate project status
deliver internal and client presentations
collect and trend process data
provide business case for process improvement projects
act as the lead for technical support deviations
maintain a high performing team by hiring
drive departmental training
author and regularly review Standing Operating Procedures
How You'll Work.
Team & Collaboration
work cross-functionally with Project Management, Manufacturing, Quality, Supply Chain, and Facilities; work cross functionally with project managers, production, label design and control, quality assurance, quality control, supply chain, and facilities departments; communicate with internal and external stakeholders; collaborate effectively across teams and with clients
Communication Scope
communicate project status; deliver internal and client presentations; communicate with internal and external stakeholders; communication skills with the ability to manage multiple priorities, deliver high-quality customer service, and collaborate effectively across teams and with clients
Process & Methodology
manage and execute assigned projects, coordinate projects, project management experience and skills preferred
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