Saint-Gobain Validation Engineer in Beaverton, Michigan
**This position could be filled in either our Beaverton, MI location or our Gaithersburg, MD location.
This position is responsible for leading the validation activities for the Application Engineering Team. Drafting protocols and test methods, conducting testing and initiating statistical analysis of process test results. The Validation Engineer will create project plans, supervise project teams and coordinates with all departments associated with new projects. Process sterility, shelf life assessment for all new single use projects. This role will also initiate risk assessments development for project design before quoting and development, as well as coordinate the proper test methods for single use assemblies.
Background using a Quality Control Platform and working knowledge IQOQPQ process.
Particulate-Bioburden, Endotoxin and Sterility knowledge.
Skilled in Microsoft Office and QAD or similar manufacturing software. USP and ISO knowledge for medical and biopharma industry
Ability to work well with ever changing priorities and/or situations.
High level of technical knowledge for custom manufacturing processing, which includes BOM, product structures and fixturing.
Lead validation activities in coordination with Applications, Quality and Manufacturing on single use development programs on daily basis
Oversee documentation standards for testing, monitoring and evaluating Application Engineering process.
Control processes and document development for tool assessment and design. Verification of Product Capability Questionnaire.
Support Application Engineering Supervisor on day to day activities including costing, design and testing.
Support standard for validation and regulatory requirements for existing and new raw materials.
Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.