This position supports the qualification and validation activities at Grand River Aseptic Manufacturing Inc. These duties include, but are not limited to: protocol writing, execution of study protocols, and final report generation in order to provide assurance that all Critical Quality Attributes, Critical Process Parameters and Critical Aspects have been thoroughly tested and validated.
- 5 to 8 years of experience in validations within an API, pharmaceutical, or biotech industry is required.
- Experience in computer systems validations is preferred
- Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations a must.
- Knowledge of the basic principles of validation across multiple disciplines, for example, equipment, utilities, software, and cleaning and process validations.
- Knowledge of GAMP5, ISPE Baseline Guides for Commissioning and Qualification and ASTME2500.
- Associate or Bachelor’s degree in life sciences or engineering, or equivalent training and/or experience.
If you would like to be considered, please submit your resume on our careers page.