Aseptic Technician

Actively Interviewing for Aseptic Technician to Join Global Animal Health Client in Lithia Springs, GA!

The Aseptic Technician performs a wide range of aseptic filling operations in a GMP-regulated environment, ensuring products are filled, handled, and documented in a sterile and compliant manner. This role combines hands-on aseptic technique, equipment setup and operation, meticulous documentation, and cross-functional collaboration to support media and engineering runs, FAT, SAT, CQV activities, and stability batches. The technician works in a startup-style, large-scale biologics facility and contributes to the development, optimization, and continuous improvement of new manufacturing processes.

Responsibilities

• Learn and consistently practice basic aseptic procedures in filling suites in accordance with training and standard operating procedures (SOPs).
• Lead aseptic filling procedures and independently operate aseptic fill suites to support routine operations, media runs, engineering runs, and stability batches.
• Clean, inspect, assemble, and prepare complex filling equipment for sterilization, ensuring all components meet aseptic and operational standards.
• Perform routine environmental monitoring, including use of settle plates, contact plates, aseptic swabbing, particle counters, and air sampling devices to verify cleanroom conditions.
• Load and unload autoclaves using approved practices to achieve and maintain equipment sterility.
• Train in and apply Good Manufacturing Practices (GMPs) to all assigned work, ensuring compliance with regulatory and internal quality standards.
• Document all processes accurately, legibly, and completely in accordance with SOPs and GMPs, including batch records and associated documentation.
• Assist with final compilation of filling documentation packages and perform final checks of process worksheets for completeness and accuracy.
• Learn and apply relevant USDA and APHIS requirements related to aseptic filling operations.
• Assist with mechanical setup procedures in an aseptic environment and independently perform mechanical setups for filling equipment.
• Use balances, pipettes, scientific calculators, and other measuring devices to establish, verify, and document fill volumes.
• Assist with operation of CIP/SIP systems (clean-in-place and sterilize-in-place) to ensure equipment is properly cleaned and sterilized.
• Monitor and maintain staged material inventories to support day-to-day operations in the filling suites.
• Evaluate production requirements and order supplies and sterile equipment from support departments to ensure timely delivery for scheduled operations.
• Use SAP to check inventory status and location, and perform location changes, component issue transactions, and scrap transactions as needed.
• Assist with troubleshooting and problem-solving for aseptic and mechanical issues, working with cross-functional teams to resolve problems quickly.
• Identify and propose process improvements, using statistical concepts to evaluate and report process effectiveness and outcomes.

Essential Skills

• 1–2 years of experience working in an aseptic environment, including aseptic technique, sanitization, and cleanroom practices.
• Experience in GMP and FDA-regulated manufacturing environments.
• Experience in aseptic filling or a closely related field.
• Knowledge of Good Manufacturing Practices (GMPs), SOPs, and relevant regulatory expectations.
• Ability to operate and maintain specialized aseptic filling equipment and related support systems.
• Proficiency with scientific measuring devices such as balances, pipettes, and other laboratory instruments.
• Ability to perform basic and intermediate mathematical calculations, including dilutions, concentrations, and volume verifications.
• Strong attention to detail and ability to maintain accurate, complete, and compliant records.
• Experience using SAP for inventory inquiries, location management, component issuance, and scrap transactions.
• Familiarity with environmental monitoring (EM) activities and techniques in cleanroom environments.
• Ability to use statistical concepts to evaluate and report process effectiveness.
• Excellent communication and interpersonal skills to…