Manufacturing Technician responsible for supporting GMP Fill Finish manufacturing processes, including aseptic production of finished drug product biologics, through application of knowledge of theories, techniques, and principles.
Requirements
- Complete and maintain aseptic qualification training.
- Obtain basic understanding of a task, unit operation and/or document while aiding with oversight from Manufacturing Technician III and above.
- Attain and maintain gowning qualification per appropriate SOPs.
- Follow SOPs, product batch record instructions, logbooks and forms, and corresponding quality documentation in detail.
- Prepare and maintain accurate documentation following cGMP and GDP principles.
- Ensure documentations are completed in real-time in accordance to CGMP and GDP principles.
- Adhere to all environmental, health, and safety policies and procedures and proactively identify unsafe conditions.
- Support QC sampling, equipment calibration, equipment/utility validation, and preventive maintenance as needed.
- Work collaboratively with internal teams to meet site goals and objectives as part of a team.
- Initiate and foster a spirit of cooperation within and between departments.
- Review documentation for accuracy, makes corrections and/or escalates to supervision/Manufacturing Quality Associate (MQA).
- Maintain all personal cGMP related training in a current state.
- Achieve and maintain cleaning and sanitization of cleanroom training.
- Participate in Aseptic media qualification per the appropriate qualification protocol.
- Support manufacturing in the investigation of deviations and performs required risk assessments.
- Participate in personnel monitoring as requested.
- Work closely with Operational Excellence to identify and implement process improvements.
- Set up and breakdown the filling equipment per appropriate SOPs.
- Transport equipment and components as needed.
- Interact with filling machines at the validated speeds and volumes.
- Perform volume checks.
- Perform and document inherent and non-inherent interventions.
- Ensure slow and purposeful movements appropriate for a Grade A/B GMP aseptic environment.
- Work with R&D and tech transfer team for successful transfer of Programs into the GMP area
- Perform all aseptic connections, respecting first air.
- Perform pre- and post-filter integrity testing as required.
- Aseptically sterile filter products into appropriate vessels.
- Complete routine and enhanced cleaning and sanitization of all controlled aseptic cleanrooms, as needed.
- Attain and maintain ability to perform environmental tasks as required.
- Perform other duties as assigned.
Benefits
- Medical, dental, and vision insurance plans
- Paid time off
- Paid parental leave
- Company-paid holidays subject to change yearly
- 401(k) retirement plan
- Employee stock purchase plan
