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

Desired Skills and Experience

GMP manufacturing operations, equipment setup, calibration, production documentation, in-process testing, quality testing, component assembly, subassembly, final assembly, development support, clinical studies manufacturing, commercial product manufacturing, production equipment operation, troubleshooting, R&D support, process optimization, bench-top equipment, medium-scale equipment, large-scale equipment, experimental production, clinical production, process qualification, validation, SOP documentation, SOP revision, on-the-job training, safety compliance, incident reporting, equipment maintenance coordination, cross-shift communication, team collaboration, cGMP regulations, DEA regulations, OSHA regulations, drug compound handling, organic solvent handling, clean room operations, gowning procedures, multi-tasking, Microsoft Word, Microsoft Excel, biopharmaceutical industry experience, medical device industry experience, leadership skills, supervisory skills, Life Sciences, Engineering, technical documentation, process feedback, technical services interaction, facilities coordination, production goals, regulatory compliance

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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