Aseptic Technician

Aseptic Technician page is loaded## Aseptic Technician locations:
Atlanta time type:
Full time posted on:
Posted Yesterday job requisition :
JRWe’re a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries. And we’re excited to become a part of the Metro Atlanta, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios.
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* Position Summary:

** We are seeking a dedicated and detail-oriented Aseptic Filling Technician to join our team. The successful candidate will be responsible for performing various aseptic filling procedures, ensuring adherence to GMPs, and maintaining a sterile environment. This role requires a strong understanding of aseptic techniques, meticulous documentation skills, and the ability to operate and maintain specialized equipment.**(Near-term) Responsibilities in a Startup Environment:
** In a startup environment, the Aseptic Filling Technician will adapt quickly to changes, lead in developing and optimizing new processes, and identify opportunities for innovation and improvement. This role involves close collaboration with cross-functional teams, managing inventory and resources efficiently, and troubleshooting unexpected challenges. The technician will also contribute to scaling production processes, participate in diverse tasks to support the dynamic needs of the startup, and ensure the sustainability and scalability of all procedures as the company grows.  

Specific activities would include FAT, SAT, CQV, media and engineering runs that lead to stability batches.  The successful candidate will need to be flexible to perform activities outside of the standard aseptic requirements in order to assist other departments during scale up of staffing and processes.
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* Key Responsibilities:

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* ** Aseptic Procedures:**  + Learn and practice basic aseptic procedures in the filling suites per training and SOPs.  + Lead aseptic filling procedures and independently operate aseptic fill suites.  + Clean, inspect, and assemble complex filling equipment and prep for sterilization.  + Perform routine environmental monitoring, including settle plates, contact plates, aseptic swabbing, particle counts, and air sampling.  + Load and unload autoclaves using practices designated to achieve and ensure equipment sterility.
* ** GMP Compliance:**  + Train in and apply GMPs to assigned work.  + Document processes accurately and completely in accordance with SOPs and GMPs.  + Assist with final compilation of filling documentation packages and perform final checks of process worksheets.  + Learn and apply USDA and APHIS requirements related to filling operations.
* ** Equipment Operation and Maintenance:**  + Assist with mechanical set-up procedures in an aseptic environment and independently perform mechanical set-ups.  + Operate electric material handling equipment (forklift, tank puller) to move product tanks and supplies.  + Use balances, pipettes, scientific calculators, and other measuring devices to establish and verify fill volumes.  + Assist with operation of CIP/SIP systems (clean-in-place, sterilize-in-place).
* ** Supply and Inventory Management:**  + Monitor and maintain staged material inventories to supply day-to-day operations.  + Evaluate production requirements and order supplies and sterile equipment from support departments for timely delivery.  + Use SAP to inquire into inventory status, location, and perform location change, component issue, and scrap transactions.
* ** Process Monitoring and Improvement:**  + Assist with troubleshooting and problem-solving for aseptic and mechanical issues.  + Identify process improvements and suggest enhancements.  + Use statistical concepts to evaluate and report process effectiveness.
* ** Training and Leadership:**  + Participate in cross-training with other departments and in all filling suites.  + Train others in all filling operations.  + Lead improvement teams and assist with special project teams.  + Assist with routine and emergency decisions using data, good judgment, and experience.
* ** Additional Responsibilities:**  + Perform calculations as needed to prepare disinfectants, make dilutions, verify fill volumes.  + Participate in overtime rotation as required to meet fill schedules.  + Maintain personnel and production schedules to meet market requirements.  + Assist with capital purchase recommendations and gather data for monthly reports.
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* Qualifications:

*** High school diploma or equivalent is required; additional technical training or certification preferred.
* Experience in aseptic filling or a related field.
* Knowledge of GMPs, SOPs, and regulatory requirements.
* Strong attention to detail and ability to maintain accurate records.
* Proficiency with scientific measuring devices and basic mathematical calculations.
* Ability to operate and maintain specialized aseptic…