Validation experience preferred, including exposure to equipment validation and validation protocols in a manufacturing or pharmaceutical setting.
Knowledge of current Good Manufacturing Practices (cGMP), FDA regulations, and manufacturing practices to ensure regulatory compliance preferred.
Demonstrated experience, proficiency, knowledge, or training in a regulated cGMP, manufacturing, or pharmaceuticals environment preferred.
Experience in pharmaceutical manufacturing or biopharmaceutical environments is highly beneficial.
Familiarity with quality assurance and quality control principles and practices.
Understanding of aseptic techniques and clean room practices.
Ability to compile, interpret, and document observations of production processes in a clear and organized manner.
Experience supporting or executing cleaning validation and environmental monitoring programs.
Comfort working with validation protocols and documentation in a regulated environment.
Interest in continuous improvement and process optimization within validation and quality control functions.