What are the responsibilities and job description for the Manufacturing Technician, Fill Finish position at Medix?
Responsibilities :
- Complete and maintain aseptic qualification training.
- Gain foundational knowledge of tasks, unit operations, and documentation (forms / SOPs) with guidance from Manufacturing Technician III or higher.
- Maintain gowning qualifications according to relevant SOPs.
- Follow SOPs, product batch record instructions, logbooks, forms, and related quality documentation accurately and consistently.
- Ensure real-time documentation is completed in accordance with cGMP and GDP standards.
- Maintain accurate documentation in compliance with cGMP and GDP principles.
- Comply with all environmental, health, and safety policies; actively identify and address unsafe conditions.
- Assist with QC sampling, equipment calibration, equipment / utility validation, and preventive maintenance as required.
- Collaborate with internal teams to meet site objectives and contribute to team success.
- Foster a cooperative and team-oriented environment across departments.
- Review and correct documentation as needed, escalating issues to supervision or Manufacturing Quality Associates (MQA).
- Maintain up-to-date personal cGMP training records.
- Complete cleaning and sanitization training for cleanroom environments.
- Participate in aseptic media qualification according to protocol.
- Assist with investigations into deviations and conduct necessary risk assessments.
- Support personnel monitoring activities as needed.
- Work with Operational Excellence to identify and implement process improvements.
- Set up and break down filling equipment per SOPs.
- Transport equipment and components as needed.
- Operate filling machines at validated speeds and volumes.
- Perform volume checks and document inherent / non-inherent interventions.
- Maintain slow, deliberate movements in a Grade A / B GMP aseptic environment.
- Collaborate with R&D and the tech transfer team for successful program transitions into the GMP area.
- Perform aseptic connections while respecting first air.
- Conduct pre- and post-filter integrity testing as required.
- Sterilize and aseptically transfer filter products into designated vessels.
- Complete routine and enhanced cleaning and sanitization of aseptic cleanrooms as needed.
- Maintain ability to perform environmental tasks when required.
- Perform other duties as assigned.
Qualifications :
