A new Job, ID: 181074 <http://ejobsville.com/display-job/181074> was added
at eJobsVille.com - For the Best Tech Jobs in Town <http://ejobsville.com>

Title:  Process Validation Engineer  posted on 2014-06-02 17:06:40

Job Description:*Job Summary*

*Responsible for providing manufacturing validation engineering services.
Position will support internal process validations with compliance to Code
of Federal Regulations (CFR) section 820.75*

*Principal Duties and Responsibilities*

Development, execution, and reporting of CFR 820.75 compliant process
validations
Identification of key calibration requirements for equipment installation
activities
Equipment Installation Qualification for medical device production
Equipment calibrations for medical device production

Operational Qualification execution for medical devices
Production Qualification execution for medical devices
Statistical interpretation of attribute and variable results
Prepare validation summary reports
100 Total Percent (not to exceed 100%)
Individual percents should be greater than or equal to 5%.

This is not an exhaustive list of duties or functions and may not
necessarily comprise all of the "essential functions" for purposes of the
ADA.

*Expected Areas of Competence* (i.e. KSAs)
Skilled and knowledgeable in medical device manufacturing and product
processing;
Knowledge of drafting standards and geometric dimensioning and tolerancing
Demonstrates ownership of and ability to manage project assignments with a
broad scope and high level of complexity and able to prioritize and
complete work in a timely manner.
Demonstrates advanced problem solving skills through the use of quality and
statistical tools
Ability to effectively work within a team and cross functionally to
expedite completion of critical project tasks.
Experience with CNC, Wire EDM, and Ram (sinker) EDM, is preferred
Knowledge of chemical vapor deposition processes is a plus
Knowledge of medical device cleaning processes is a plus
Demonstrates excellent written and verbal communication skills
Microsoft Office Suite and Project; Statistical Process Control skills;
proficient in process development, , and MINITAB statistical software.
Knowledgeable in Good Manufacturing Practice and Good Documentation
Practices
Education/ Experience Requirements
B.S. in mechanical, industrial, chemical engineering, or other engineering
science plus 3-5 years of manufacturing process development or validation
experience, or an equivalent combination of education and experience.





*Click here to view full job description and apply
<http://ejobsville.com/display-job/181074>  (Registration not mandatory to
apply for this job)*

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