Mentor Technical Group · 4 months ago
Aseptic Process Technician/Operator (GMP)
Durham, NC
Full-time
Onsite
Entry Level
1+ years expMentor Technical Group (MTG) is a world leader in life science engineering and technical solutions, providing support for the FDA-regulated industry. They are seeking an Aseptic Process Technician/Operator to execute aseptic filling and manufacturing processes while ensuring compliance with GMP and aseptic techniques.
BiotechnologyFacility ManagementLife Science
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
Qualification
Required
High School Diploma or GED required
1–3 years of aseptic/sterile manufacturing experience in a GMP-regulated facility (pharmaceutical, biotech, or medical device)
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
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)
Preferred
Associate's or Bachelor's degree in Life Sciences, Biotechnology, or related field
Company
Mentor Technical Group
Mentor Technical Group is a minority-owned business setting new standards for multidisciplinary compliance, technical, and engineering services.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Lydmarie Llorens
HR Business Partner and Compliance Manager
Neyshia Rivera, MA
Human Resources Business Partner
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