Process Technician 3

Organization: 
Affymetrix, Inc.
Job Location: 
Cleveland, Ohio
Job Description: 

Position Description:

The instrument process engineering technician provides technical and sustaining
engineering support to the instrument product engineering organization. This
position will use technical knowledge of operations, processes, and equipment to
aid in the completion of projects aimed at reducing costs, improving quality,
improving reliability, expanding production capacity, developing new
technologies, and maintaining regulatory compliance to cGMP requirements and
ISO13485 regulations.



The instrument process engineering technician will be able to develop process
validation documents, IQ/OQ/PQ's, and other documents as required for new
equipment installs/upgrades, PMs, or troubleshooting. The instrument process
engineering technician will also coordinate all aspects of engineering projects
assigned. The incumbent in this position will coordinate the schedules for
equipment and/or processes for validation and engineering runs, and execute
engineering DOEs. The technician will adhere to all plant quality, safety, and
documentation systems requirements.



The instrument process engineering technician will support investigations of
Deviations/NCMRs, troubleshooting and assisting in solving complex processes and
equipments. The instrument process engineering technician interacts with new
product introduction teams, engineering, planning, and manufacturing to
coordinate introduction of new processes, engineering, and validation runs.

Routine responsibilities include continuous support of the instrument
manufacturing process; new product/part introduction; monitoring and support of
key manufacturing processes; conduct investigations and troubleshooting of
process failures; providing summary results of findings and recommendations to
MRB.



Position Requirements

Requires a BS degree in engineering/life science, or demonstrated experience in
cGMP/ISO13485 environment in validation or process engineering; ability to
effectively communicate (verbal and in writing) complex information and data.
Position requires work in instrument manufacturing environment, which requires
ability to wear laboratory personal protective equipment as required. Also, must
be proficient with computers and spreadsheets, word processing, database, and
MRP system (JDE preferred); must be able to keyboard for periods of time.
Position requires travel 0-10% of the time.

Contact Information: 

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