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GMP Clean-room Technician

2 months ago

Frederick, United States Intelliswift Software Full time

Title: GMP Clean-room Technician

Location: Frederick, MD

Duration: 12 Months on W2


The GMP Clean-room Technician will perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations as well as works as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance.


Responsibilities of the GMP Clean-room Technician include:

• Successfully troubleshoots processing and equipment issues while communicating said issues to management

• Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements

• Authors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements and supports efficient operations

• Routinely monitors, cleans, prepares and operates sophisticated automated cell processing, cell expansion and filling equipment in Grade B/C clean rooms

o all required PPE and gowning for classified GMP manufacturing areas is provided by the company.

• Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls


Basic Requirements:

BA / BS Degree in Sciences Field

OR

AA Degree with 1+ years of cGMP experience

OR

High School Degree and 2+ years of cGMP experience