Manufacturing Technician III

Manufacturing Technician III

W2 Contract

Salary Range: $68,600 - $74,900 per year

Location: Fremont, CA - Onsite Role

Job Summary:

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.

Duties and Responsibilities:

• Manufacture supplies for development, clinical studies, and commercial products
• 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, and 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

Requirements and Qualifications:

• 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 detail
• 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 working independently on several tasks simultaneously
• Good interpersonal skills and tact are 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
• A high school diploma or equivalent
• 4+ years of experience in the biopharmaceutical or medical device industry
• AA or AS in a Life Sciences or Engineering discipline preferred
• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods of standing.
• Must be able to lift up to 35-40 pounds at times
• Must be able to travel

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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