Perform sterile manufacturing operations, including formulation, filtration, and aseptic filling.Perform material handling, line clearance, equipment preparation, and manufacturing support activities.Operate, monitor, and troubleshoot manufacturing equipment and automated systems.Perform weight and dispense activities and solution preparation.Perform autoclave operations and visual inspections.Complete material transactions and other manufacturing support functions.Maintain accurate and complete batch records and GMP documentation.Follow Good Documentation Practices and data integrity standards.Monitor manufacturing processes and identify safety, quality, and efficiency opportunities.Support investigations, deviations, change controls, CAPAs, and corrective actions.Assist with equipment qualification, validation, and continuous improvement activities.Cross-train across multiple manufacturing areas to support operational needs.Identify and escalate equipment, process, safety, or quality concerns.Maintain compliance with cleanroom, PPE, GMP, and aseptic gowning requirements.
1-4 years
Associate or Bachelor's degree in Life Sciences, Engineering, or a related field.Biopharmaceutical manufacturing experience.Experience with sterile filtration and aseptic filling.Experience with formulation and solution preparation.Experience with autoclave operations.Experience operating and troubleshooting automated manufacturing equipment.Experience with weight and dispense activities.Experience with batch records and GMP documentation.Experience supporting deviations, CAPA, investigations, or change controls.Experience with equipment qualification and validation.Experience working in classified cleanrooms.Experience with continuous improvement initiatives.
Minimum 2 years of GMP manufacturing or related technical experience.Knowledge of GMP manufacturing operations and procedures.Ability to operate and troubleshoot manufacturing equipment.Ability to follow sterile manufacturing procedures.Ability to accurately complete manufacturing and quality documentation.Knowledge of Good Documentation Practices and data integrity.Ability to work in controlled cleanroom environments.Ability to gown and work in classified manufacturing areas.Ability to manage multiple manufacturing activities and priorities.Effective written and verbal English communication skills.Ability to use computers and manufacturing systems.Ability to lift up to 25 pounds occasionally.Ability to pass required color vision testing.
Bachelors
We are here to help you with your questions.