BS Mechanical Engineering with a minimum of five years of
experience in manufacturing in a cGMP environment in the biotech, medical device
or pharmaceutical industries.
Skills:
Strong leadership skills
Working knowledge of cGMP requirements.
Strong documentation skills.
Detail oriented.
Strong problem solving skills
Effective verbal and written communication skills in English.
Ability to read and understand blueprints to ANSI standards
Ability to operate engine lathe and vertical milling machine.
Knowledge/ability to diagnose and/or repair common and prototype production machinery.
Understanding and knowledge of machine I/O, AC electrical and DC electrical distribution.
Ability to apply safe and proper machine shop practice to practical use.
Ability to lift up to 50 pounds
Working knowledge and experience with PC, and MS Office applications.
Minimum of one year experience parametric modeling, SolidWorks or ProE equivalent.
Essential Functions:
Perform IQ, OQ, and PQ on new manufacturing equipment, including
documentation of these activities in the form of Protocols and Reports.
2. Write and revise MOP’s, Preventative Maintenance
Procedures and Work Instructions for the use and maintenance of manufacturing
equipment.
Train manufacturing personnel to operate equipment.
Provide operations support by problem evaluation, determination
of root cause and corrective action.
Assemble prototype and production equipment including VAC
distribution, VDC distribution and I/O wiring.
Maintain semi-complex to complex production equipment
(motion control, electrical, pneumatic systems).
Design and write low level ladder logic and single line
code/scripts for PLC and motion controllers.
Respond in a timely manner to Manufacturing needs and repair
and maintain production and test equipment.
Manage preventative maintenance program for manufacturing
equipment and ensure preventative maintenance is kept on schedule and documented.
Maintain inventory of supplies and spare parts for Manufacturing.
Design basic fixtures and electro/pneumatic devices using parametric
modeling applications.
Assist in the design of prototype machinery, including machining parts
to blueprint and validation of equipment and tools in manufacturing.
Extended working hours may be necessary at times.
Additional Responsibilities
Perform other duties as necessary.
Submit Resume or CV to:
Human Resources
Hitachi Chemical Diagnostics
630 Clyde Court
Mountain View, CA 94043
Fax: 650 969 2745
E-mail: webmaster@hcdiagnostics.com
Subject: Staff Engineer
hitachi.com 
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