Aseptic Filling Technician I/II (3rd Shift)

Tech I Responsibilities

• Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals
• Class A/B gowning qualified for facility cleaning of fill suites
• Operate support fill equipment such as the glass inspection stations, rinser/tunnel, VAM and over sealer
• Load carts with vials or syringes
• Perform SIP Operations and filter integrity testing
• Prepare chemical solution for production use
• Strict adherence to Dept. Safety Rules
• Perform material handling and glass inspection activities
• Detailed, general facility housekeeping i.e. minor cleaning, keeping work and production area neat and free from clutter
• Cleaning - Sanitization per procedures, documentation of sanitization, mopping, disinfecting (floors, walls, equipment)
• Operate motorized (ie Fork truck, lift jack, etc.) transport equipment for moving supplies
• Real time documentation (i.e. BPR) during production run and maintain accurate records/logs
• Monitor and operate various computer control systems for production activities i.e. SCADA and Andover

The Technician II independently performs fundamental tasks within a GMP environment by cleaning and maintaining the workplace. The Technician II will independently dissemble, clean, and reassemble equipment for production activities, perform process control manipulations, use various computer control systems and analytical equipment to perform real time documentation in appropriate production procedures while maintaining accurate records and logs. The Technician II will be expected to recognize and identify safety hazards, perform basic training to less experienced personnel, and utilize troubleshooting skills in alignment with job responsibilities.

Tech II Responsibilities

• Prepares and properly labels according to BPR and non-routine request
• Independently interprets and utilizes information from company support systems
• Maintaining all training responsibilities associated with the Technician II level
• May operate and monitor final container lyophilization, heat treatment, pasteurization and cold box
• Operate and filer integrity tester and gas chromatography for lexsol detection
• Demonstrates department specific aseptic techniques and capabilities
• Performs all duties described at the Aseptic Filling Level
• Accurate documentation skills
• Basic computer skills
• Mechanical aptitude
• Ability to work well with others in a team environment
• Self-starter with the ability to work independently and use good judgement
• Able to handle multiple priorities
• Proactive, results oriented, and strong attention to detail
• Maintain acceptable aseptic gowning qualification and media fill certification
• Setup and operate equipment within an aseptic environment
• Utilize troubleshooting skills in alignment with job scope responsibilities to provide solutions
• Assist with initial responsibilities for the Technician level
• Trains less experienced Technicians in the use of applicable computer systems

Knowledge, Skills & Abilities

• Must possess a good math and mechanical aptitude with the ability to perform skills in an aseptic environment
• Production work experience in a high-volume manufacturing environment is desired
• Must be able to function in an aseptic environment while maintaining the sterility of the product
• Able to work effectively and efficiently as a member of a team
• Able to lift up to 50 pounds
• Continuous standing, walking and some bending is required
• Off shift and overtime work may be necessary

Requirements

• High School Diploma
• Bioworks Certification preferred