Aseptic Process Technician/Operator (GMP) na Mentor Technical Group

Execute aseptic filling, compounding, and manufacturing processes in compliance with GMP and aseptic techniques.

Operate, monitor, and maintain equipment used in sterile drug product manufacturing.

Perform environmental monitoring and in-process checks to ensure compliance with aseptic conditions.

Prepare, stage, and sterilize equipment, components, and materials for aseptic operations.

Document activities accurately and completely in batch records, logbooks, and electronic systems according to GDP (Good Documentation Practices).

Assist in equipment setup, changeover, and routine troubleshooting.

Collaborate with Quality Assurance, Engineering, and Validation teams to support production and resolve deviations.

Adhere strictly to gowning procedures, aseptic techniques, and cleanroom behaviors.

Support continuous improvement initiatives to optimize processes, reduce risks, and ensure regulatory compliance.

Education: High School Diploma or GED required; Associate’s or Bachelor’s degree in Life Sciences, Biotechnology, or related field preferred.

Experience: 1–3 years of aseptic/sterile manufacturing experience in a GMP-regulated facility (pharmaceutical, biotech, or medical device).

Knowledge:

• Strong understanding of aseptic processing principles, cleanroom classifications, and sterile technique.

• Familiarity with GMP, FDA, and regulatory requirements for sterile manufacturing.

• Knowledge of environmental monitoring practices and sterile equipment operation.

Skills:

• Excellent attention to detail and ability to maintain sterility standards.

• Strong documentation and organizational skills.

• Ability to follow strict written procedures and SOPs.

• Team-oriented mindset with effective communication skills (written and verbal).

• Basic computer literacy (MS Office, electronic batch records a plus).