Aseptic Process Technician / Operator (GMP)

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 :

Experience :

Knowledge :

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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.