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Requisition Number 17-0007
Post Date 2/6/2017
Title Mfg Tech/Sr Mfg Tech
City Mountain View
State CA
Description • Independently perform a variety of complex tasks to support commercial manufacturing & ongoing RD activities
• Interact with RD & Technical Services personnel to provide input for protocol development & assistance with execution. Independently set-up, operate, troubleshoot & dismantle a broad range of equipment (bench-top, medium, large scale) used for the manufacturing of Alexza products
• Complete GMP documentation & initiate investigations when deviations occur
• Assume the responsibilities of Lead/Supervisor when regular Supervisor is absent
• Generate & revise SOPs & Production Records
• Provide on-the-job & SOP training including facilitating group training
• Ensure a safe work environment is maintained & initiate & investigate Safety Incident Reports when they occur
• Interact with Maintenance & Facilities to ensure equipment & facilities are maintained in good working order
• Ensure that all pertinent issues are communicated between shifts & to support personnel. (as required)
Requirements Skills required:
• Able to provide direction, coaching, & training for other Manufacturing Technicians
• Ability to master process unit-operations & train others
• Strong GMP documentation skills
• Excellent oral & written communication skills in English
• Demonstrates good judgment within defined procedures & practices to determine appropriate action
• Strong mechanical aptitude with the ability to troubleshoot highly technical & process related issues. Experience with handling drug compounds & solvents as well as with automated equipment.
• Strong understanding of cGMP, DEA & OSHA regulations. Ensure tasks are performed in accordance with Good Manufacturing Practices (GMPs) as detailed by the U.S. & European Regulatory Agencies
• Able to work flexible hours & capable of independently leading multiple tasks
• Must work in a clean room environment & conform to gowning & safety requirements
• Strong interpersonal skills & tact needed to interact with personnel from a wide range of disciplines & management levels
• Good computer skills, including; MS Word & Excel
• Ability to lift 35-40 lbs. essential

Education & experience:
• A high school diploma or equivalent experience
• 8+ years of experience in the biopharmaceutical or medical device industry
• AA or AS in a Life Sciences or Engineering discipline or combination of 4 years industry experience with BS degree in Life Sciences or Engineering discipline preferred
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