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Requisition Number 18-0009
Post Date 11/2/2018
Title Manufacturing Technician
City Mountain View
State CA
Description Alexza Pharmaceuticals is looking for an experienced production operator to work day shift who has the experience and desire to take their career to the next level. We are looking for someone who can step in and make an immediate impact on our manufacturing team. The ideal candidate must be comfortable working in an R & D startup environment while possessing a strong commercial skillset.

If you are interested in a position that has potential for growth by showing off your automation and mechanical skills (while highlighting the cGMP and FDA regulatory knowledge) come join our growing team.

• Independently perform a variety of minor to 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, to custom 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

Requirements Skills required
• Strong mechanical aptitude with the ability to troubleshoot highly technical and process related issues.
• 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
• 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
• A good working knowledge of Agile is a plus
• 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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