Job Description Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling Coordinates purchase and delivery of Equipment/Tooling Coordinates installation of Equipment/Tooling Develops and Executes IQ and OQ Protocols and Reports Develops and Executes Test Method Validations / Gage R&R Generates and Issues for Approval SOPs and Manufacturing Procedures Develops and Executes Component Qualifications Develops and Executes PQ and PPQ Protocols and Reports Develops Manufacturing Capacity Analysis Develops and Executes Process Characterizations / Design of Experiments (DOE) Develops documentation/justification for assigned capital projects Complies with cGMP's, Quality Standards , and established policies and procedures Executes other duties assigned by his supervisor Education and/or Experience: Bachelor's Degree in Engineering Experience in the Medical Device / Pharmaceutical Industries: Yes 5+ years of experience in the following fields: Manufacturing New Product Transfers Product / Process Development
Numbers & Facts
Location
El Paso, TX
Industry
Other/Not Classified
Company Size
100 to 499 employees
Skills
Biotech and Pharmaceuticalunmatched
Capacity Analysisunmatched
Capital Projectunmatched
Documentationunmatched
Experiment Designunmatched
Machine Toolunmatched
Manufacturingunmatched
Manufacturing Analysisunmatched
Manufacturing Engineeringunmatched
Medical Equipmentunmatched
Process Developmentunmatched
Process Validationunmatched
Quality Assurance Methodologyunmatched
Standard Operating Procedures (SOP)unmatched
Test Plan/Scheduleunmatched
United States Department of Energy (DOE)unmatched
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