Manufacturing Technician III in Fremont
Energy Jobline ZR, Fremont, CA, United States
Job 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 SOPs 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 seamlessly 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
Good computer skills, including but not limited to MS Word and Excel
Education Required
A high school diploma or equivalent
4+ years experience in the biopharmaceutical or medical device industry
AA or AS in Life Sciences or Engineering discipline
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer
Potentially prolonged periods standing
Must be able to lift up to 35‑40 pounds at times
Must be able to travel
Compensation
$32–38/h commensurate with experience
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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 SOPs 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 seamlessly 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
Good computer skills, including but not limited to MS Word and Excel
Education Required
A high school diploma or equivalent
4+ years experience in the biopharmaceutical or medical device industry
AA or AS in Life Sciences or Engineering discipline
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer
Potentially prolonged periods standing
Must be able to lift up to 35‑40 pounds at times
Must be able to travel
Compensation
$32–38/h commensurate with experience
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