BS/MS in Chemistry/Biology/Engineering or equivalent with
min 5yrs manufacturing experience in a cGMP environment within the medical device
or in vitro diagnostics industry.
Skills:
Strong ability to create commitments and plans and motivate employees to achieve
them as a group.
Good trouble-shooting, root cause analysis, including the use of SPC and other
modern manufacturing analytical skills, and hazard analysis skills.
Good ability to teach, guide and communicate with own group and with peers
from other departments.
Good mechanical aptitude and knowledge of process and equipment validation.
Effective verbal and written communication skills in English.
Ability to work cooperatively in a team environment.
Essential Functions:
Transfer new products and processes to manufacturing by
collaborating with R&D.
Aid in leading OPTIGEN manufacturing towards successful
implementation of full factory scale up.
Drive the department for daily and mid range improvement
for quality improvement and cost reduction.
Ensure on time manufacturing as per Operations schedule.
Maintain the production facilities, production processes,
equipment and documentation in accordance with cGMP and ISO 13485 requirements
at all times.
Train personnel to comply with cGMP.
Play an active role in the development of employees’
careers.
Participate in the design, execution, documentation of
experiments, equipment and process validations to scale-up and improve
quality and efficiencies of operations.
Evaluate, qualify and validate new equipment in conjunction
with process engineer.
Responsible for focal reviews for all OPTIGEN manufacturing
personnel.
Write and revise Batch Records, Standard Operating Procedures,
Validation Protocols, Acceptance Reports and other documents as needed.
Perform other duties as necessary.
Extended working hours will be necessary.
Physical Demands:
Position requires the ability to sit, stand, walk, talk
and hear. Specific vision abilities include close and
distant vision.
Work Environment:
While performing the duties of this job, the employee will
work with chemicals and hazardous materials and work in a refrigerated area for
up to 30 minutes at a time.
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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: Manufacturing Supervisor - OPTIGEN
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