Senior Operations Technician

Role

Hands-on technician supporting GMP sterile formulation and clinical supply manufacturing in a biopharma setting, specifically in filling, lyophilization, and capping.
Responsibilities

perform sterile filling operations, equipment setup, changeovers, adjustments, environmental sampling, and documentation;
support equipment commissioning, qualification, and process troubleshooting;
collaborate with formulation, engineering, quality, and safety teams to ensure GMP compliance and process improvements.
Requirements

High School diploma or Associate degree;
minimum 2 years' experience in manufacturing, military, or industrial environments involving complex equipment;
proficiency with automated systems, HMI, SAP, and calibration databases;
ability to lift 50 lbs, work in cleanroom gowning, and perform physical tasks.
Preferred

experience in regulated biopharma manufacturing, aseptic processing, automated equipment, sterile operations, and knowledge of FDA or cGMP standards;
technical certifications or bioWork certification are advantageous.
HighValue

sterile drug product manufacturing
GMP compliance
automated filling/lyophilization/capping
aseptic processing
working in Grade C cleanroom
equipment troubleshooting
environmental monitoring
collaboration across manufacturing, quality, and engineering functions.
WorkSetup

100% on-site in Rahway, NJ; overtime expected.

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