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Calibration Systems Specialist II

Alexza Pharmaceuticals

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Location: Mountain View, CA, CA Posted Date: 4/22/2013 Position Type: Full time Job Code: 13-0027 Required Education: High school or equivalent Areas of Expertise Desired: Facilities Management

Description

Alexza Pharmaceuticals, located in Mountain View, CA, is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions, including agitation, acute repetitive seizures and insomnia. Alexza's products are based on the Staccato® system, a hand-held inhaler that is designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.

ADASUVE® (Staccato loxapine) is Alexza’s first approved product, which was approved by the U.S. Food and Drug Administration in December 2012 and by the European Medicines Agency in February 2013. Grupo Ferrer Internacional, S.A. is Alexza’s commercial partner for ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries. The commercial launch of ADASUVE is planned for the third quarter 2013 in the U.S. and Europe.

Responsibilities:
•   Coordinate all calibration related activities with in-house equipment owners and outside Calibration Service Providers.
•   Maintain calibration database, input new equipment & status of existing equipment/information and coordinate calibration activities with qualified vendors for GMP operations.
•   Responsible for maintenance, testing, troubleshooting, calibration and repair on a variety of circuits, components, analytical equipment and instrumentation for laboratory and manufacturing equipment.
•   Prepare technical reports with recommendations for solutions to technical problems.
•   Assist with revision and/or development of SOPs as needed.
•   Follow SOPs to insure calibration and preventative maintenance of equipment including certifications are within cGMP/cGLP guidelines.
•   Review & maintain calibration certification records to ensure compliance. Provide equipment status updates, history files & compliance reports.
•   Assist with various other Facilities duties.

Requirements

Skills required:
•   General knowledge of pharmaceutical manufacturing processes desired.
•   Ability to work independently to support lab equipment and manufacturing facilities.
•   Strong written and verbal communication, organizational and prioritization skills.
•   Ability to handle multiple priorities in a project driven environment.
•   Ability to work in a team environment and able to collaborate with others throughout the R&D and business organization.
•   Ability to maintain detailed and accurate records.
•   Proficient in the use of a wide variety of computer applications including CalMan, BMRAM, MS office, Excel and data base management systems.
•   Be able to lift 50 pounds.
•   Be able to climb up ladders and work in interstitial spaces.
•   Be able to wear a respirator.
•   Be able to read blueprints.
•   Be able to use general hand tools and test equipment.

Education and experience:
•   At least 2 years’ experience in biopharmaceutical cGMP operations or AA in a technical field such as instrumentation with at least 4 years related experience

We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth.

Alexza Pharmaceuticals is an Equal Opportunity Employer. Direct Applicants only - NO AGENCIES, PLEASE.
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