Aseptic Process Technician/Operator (GMP)
Aseptic Process Technician/Operator (GMP)
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Job Description
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.
Education: High School Diploma or GED required; Associates or Bachelors degree in Life Sciences Biotechnology or related field preferred.
Experience: 13 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 recibirn consideracin para el empleo sin importar raza color religin sexo orientacin sexual identidad de gnero informacin gentica 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.
Required Experience:
Senior IC
Employment Type
Full-Time
