Aseptic Process Technician / Operator (GMP)

Job Description

Job Description

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets : United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities :

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.

Qualifications Requirements / Knowledge / Education / Skills :

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).

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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