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Requisition Number 18-0009
Post Date 9/28/2018
Title Manufacturing Technician
City Mountain View
State CA
• Independently perform a variety of complex tasks to support commercial manufacturing and ongoing RD activities
• Interact with RD and Technical Services personnel to provide input for protocol development and assistance with execution.
• Independently set-up, operate, troubleshoot and dismantle a broad range of equipment (bench-top, medium, large scale) used for the manufacturing of Alexza products
• Complete GMP documentation and initiate investigations when deviations occur
• Work directly with manufacturing supervisor and manufacturing engineer in revising and updating production SOP’s and MOP’s
• Provide on-the-job and SOP training including facilitating group training
• Ensure a safe work environment is maintained and initiate and investigate Safety Incident Reports when they occur
• 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 and to support personnel. (as required)

Skills required
• Ability to master process unit-operations and train others
• Strong GMP documentation skills
• Excellent oral and written communication skills in English
• Demonstrates good judgment within defined procedures and practices to determine appropriate action
• Strong mechanical aptitude with the ability to troubleshoot highly technical and process related issues.
• Experience with handling drug compounds and solvents as well as with automated equipment.
• Strong understanding of cGMP, DBA and OSHA regulations.
• Ensure tasks are performed in accordance with Good Manufacturing Practices (GMPs) as detailed by the U.S. and European Regulatory Agencies
• Able to work flexible hours and capable of independently leading multiple tasks
• Must work in a clean room environment and conform to gowning and safety requirements
• Strong interpersonal skills and tact needed to interact with personnel from a wide range of disciplines and management levels
• Good computer skills, including; MS Word and Excel
• Ability to lift 35-40 lbs. essential

Education and experience
• A high school diploma or equivalent experience
• 4-12 years of experience in the biopharmaceutical or medical device industry
• AA or AS in a Life Sciences or Engineering discipline or combination of trade industry experience a plus
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