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