Location: Fremont (United States)
Sector: Pharmaceutical and biopharmaceutical
Vacancies: 1
Work modality: On siteJob Summary
The Manufacturing Technician III performs functions associated with all GMP manufacturing operations, including working with engineers in set-up and calibration tasks, production documentation, as well as performing in-process and quality testing related to product parts, components, subassemblies and final assemblies.
Responsibilities
• Manufacture supplies for development, clinical studies, and commercial product
• Independently set-up, operate and troubleshoot production equipment
• Independently perform complex tasks to support R&D and development activities
• Interact with R&D and Technical Services personnel to provide assistance in the optimization of processes
• Set-up, operate, and troubleshoot a broad range of equipment (bench-top, medium, large scale)
• Execute experimental, clinical and process qualification and validation production activities
• Provide feedback to project personnel on issues related to the process, testing and operations
• Update and revise SOP’s and documentation and provide on-the-job training to other Technicians
• Ensure a safe work environment is maintained at all times and follow up with Safety Incident Report investigations
• Interact with Maintenance and Facilities to ensure equipment and facilities are maintained in good working order
• Ensure that all pertinent issues are communicated between shifts (as required)
• Participate as and interact with Manufacturing Team members seemlessly to attain production goals
Skills Required
• Able to work independently in a dynamic, multi-tasking and cross-functional environment
• Strong oral and written communication skills in English
• Demonstrates good judgment within defined procedures and practices to determine appropriate action
• Strong organizational skills with keen attention to details
• Self starter who takes initiative and is able to work with minimal supervision
• Good understanding of cGMP, DEA and OSHA regulations
• Good mechanical aptitude and experience in handling drug compounds and organic solvents
• Must perform duties in accordance with current Good Manufacturing Practices (cGMPs) as detailed by the U.S. and European Regulatory Agencies
• Must work in a clean room environment and conform to specific gowning and safety requirements
• Willing and able to work flexible hours and capable of work independently on several tasks simultaneously
• Good interpersonal skills and tact needed to interact with personnel from a wide range of disciplines
• Some leadership and/or supervisory skills preferred
• Good computer skills, including but not limited to MS Word and Excel
Education Required
Physical Requirements
Compensation:
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