Job Description

The Aseptic Processing Technician plays a critical role in maintaining aseptic conditions and executing sterile operations in a cGMP-regulated environment. This position is responsible for performing , operating fill/finish systems, supporting contamination control practices, and documenting all data in accordance with FDA, cGMP standards.

About the Role

The plays a critical role in maintaining aseptic conditions and executing sterile operations in a cGMP-regulated environment.

Responsibilities

Sterility Testing & Aseptic Techniques:

• Follow aseptic gowning and cleanroom protocols to prevent microbial contamination.
• Maintain and monitor cleanroom environments, including particle and microbial sampling.

Fill/Finish Equipment Operation:

• Operate and maintain automated/manual injection systems for sterile product transfer or vial filling.
• Perform system sanitization, set-up, calibration, and troubleshooting as needed.
• Record data and maintain logs for each aseptic operation in accordance with cGMP documentation requirements.

Equipment & Environment:

• Clean, disinfect, and maintain sterile equipment and cleanroom environments.
• Perform validations and ensure equipment remains within operational specifications.

Documentation & Compliance:

• Accurately complete batch records, and equipment maintenance records.
• Adhere strictly to SOPs, cGMP, and FDA regulations during all aseptic operations.
• Report deviations, non-conformances, or contamination events immediately to quality assurance.

Qualifications

• Education: Associate’s or Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related field preferred.
• Experience: 1–3 years in a GMP-regulated sterile manufacturing or laboratory environment preferred. Experience with sterile technique, injectors, or fill/finish systems a plus.

Required Skills

• Strong attention to detail and ability to follow procedures precisely.
• Familiarity with GMP, FDA standards
• Ability to work in cleanroom gowning and controlled environments.
• Excellent written and verbal communication skills.

Preferred Skills

• Experience with sterile technique, injectors, or fill/finish systems a plus.

Pay range and compensation package

Compensation based on experience

Equal Opportunity Statement

We are committed to diversity and inclusivity in our hiring practices.

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