Aseptic Technician Level 1 - Afternoon Shift

at  Bimeda

JOB SUMMARY

Reporting to the Production Supervisor, the Aseptic Technician Level 1 is responsible for cleaning, sterilizing and setting up the room and equipment in preparation for the aseptic manufacture of products, in compliance with cGMP, SOPs and Bimeda quality standards.

Technical & Physical Capabilities:

• 1-2 years in a Pharmaceutical manufacturing GMP environment
• High School Diploma or GED
• Excellent math skills. Good command of the English Language, verbal, reading and writing
• Strong hand & eye coordination. Able to lift and move heavy objects 20 – 30kg, visual acuity, manual dexterity, some repetitive movements. Requires sustained motion of arms at all levels and fine finger activities including gripping, pinching and pulling. Must be able to work while wearing full protective gowning for entire shift.
• High integrity, excellent attention to detail, ability to organize and prioritize, and work in team environment, take initiativ

• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning and working in the sterile and controlled areas.
• Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace.
• Cleans and disinfects doors, floors, walls, ceilings and filling equipment using aseptic technique with the correct chemicals, and cleaning equipment in critical and control areas following all applicable SOP.
• Conducts the disassembly, product removal, changeover, functionality testing and cleaning and disinfection of fillers. Washes, reassembles and wraps equipment for autoclave loads.
• Works closely with the batching staff to conduct Clean Room activities associated with CIP, SIP and product filtration.
• Test runs equipment to ensure changeover of filling lines is correct and operational.
• Loads and unloads dry heat sterilization oven and autoclaves.
• Transfers sterilized equipment, components and bottles to each of the filling lines.
• Conducts filtration of WFI for cleaning activities.
• Documents all activities as they occur in log books and Production dockets.
• Stocks supplies and removes garbage as required.
• Assists the Aseptic Technician level 2 with the training of new operators as required.
• Other duties as assigned.

Technical & Physical Capabilities:

• 1-2 years in a Pharmaceutical manufacturing GMP environment
• High School Diploma or GED
• Excellent math skills. Good command of the English Language, verbal, reading and writing
• Strong hand & eye coordination. Able to lift and move heavy objects 20 – 30kg, visual acuity, manual dexterity, some repetitive movements. Requires sustained motion of arms at all levels and fine finger activities including gripping, pinching and pulling. Must be able to work while wearing full protective gowning for entire shift.
• High integrity, excellent attention to detail, ability to organize and prioritize, and work in team environment, take initiative