What are the responsibilities and job description for the Manufacturing Technician, Fill Finish - 235600 position at Medix™?
Job Title: Aseptic Technician
About the Role:
This position is responsible for supporting the manufacturing process in a GMP environment. The successful candidate will have a strong understanding of aseptic techniques and cGMP principles.
Main Responsibilities:
- Complete and maintain aseptic qualification training
- Maintain foundational knowledge of tasks, unit operations, and documentation 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
Qualifications:
- High school diploma or equivalent with 1-3 years of experience, a Bachelor's degree with at least 1 year of experience, or a combination of education and experience providing necessary knowledge and skills
- Previous experience in a related field preferred
- Familiarity with cGMP manufacturing preferred
- Knowledge of aseptic filling and general production preferred
- Basic math skills required
- Ability to establish positive working relationships with colleagues, vendors, and supervisors
- Technical knowledge to make informed decisions with minimal supervision
- Ability to analyze data, resolve complex problems, and assess situations effectively
- Proficient in following applicable SOPs
- Familiarity with electronic Quality Management Systems (e.g., MasterControl, Trackwise) is a plus
- Understanding of federal, local, and international regulations for drug substance and product production, testing, and release
- Strong understanding of cGMPs, industry standards, and regulatory guidelines
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Project, Teams, Outlook)
- Demonstrated integrity and professionalism
- Effective written and verbal communication skills with management, staff, regulators, and clients
- Ability to complete tasks accurately within established and evolving timelines
- Capable of making sound decisions on scheduling, resource allocation, and priorities
- Energetic, results-driven, self-motivated, and well-organized in high-pressure, deadline-oriented environments
- Creative, open-minded, and promotes idea-sharing within the team
- Comfortable working with diverse customer and employee groups both internally and externally
- Ability to collaborate effectively within cross-functional teams
- Must be fluent in English and have legible handwriting
