Process Validation Eng (#1936)
Company Name:
Career Transitions, LLC
Our client, located in Warsaw, IN, is looking for a Process Validation Engineer for a 1 year contract.
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
Skills
Skilled and knowledgeable in medical device manufacturing and product processing;
Knowledge of drafting standards and geometric dimensioning and tolerancing
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
Education/ Experience Requirements
Bachelors degree (Manufacturing, ME, MET, Industrial, etc.) MUST have 2yrs minimum experience with validating manufacturing processes
Estimated Salary: $20 to $28 per hour based on qualifications.
Career Transitions, LLC
Our client, located in Warsaw, IN, is looking for a Process Validation Engineer for a 1 year contract.
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
Skills
Skilled and knowledgeable in medical device manufacturing and product processing;
Knowledge of drafting standards and geometric dimensioning and tolerancing
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
Education/ Experience Requirements
Bachelors degree (Manufacturing, ME, MET, Industrial, etc.) MUST have 2yrs minimum experience with validating manufacturing processes
Estimated Salary: $20 to $28 per hour based on qualifications.
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