Employee is responsible to adhere to the GMP requirements defined within 21 CFR parts 210 &211, 820, ICH Q7, Safety standards set under ISO 14001 & 45001. This position primarily involves the safe and efficient manufacturing of active pharmaceutical ingredients (API’s) according to current Good Manufacturing Practice (cGMP) requirements. The role of Pharmaceutical Manufacturing Technician is a lab-based role primarily focused on supporting and executing activities in the manufacturing environment, including but not limited to: equipment cleaning and setup, verification tasks during GMP manufacturing, maintaining the safety and quality of the manufacturing environment, and other production tasks as directed. D shift is Thursday-Sunday 6:30pm-7:00am, then Friday-Sunday 6:30pm-7:00am. Ensure safety and cleanliness in production areas, focusing on potent compound handling techniques. Utilize and update various written procedures, including batch records and operating procedures. Serve as a primary or secondary operator for cGMP production of APIs and intermediates. Operate production equipment effectively during production, cleaning, and maintenance. Communicate production status clearly using shift pass-off tools and computer systems. Address safety and process issues identified during inspections and audits promptly. Participate in a collaborative, multi-shift manufacturing environment and support departmental responsibilities as directed by leadership. Physical Attributes: Stand for long periods of time, lift and move up to 50 pounds with the assistance of equipment or teammates as necessary. Utilize proper personal protective equipment (PPE), including respiratory protection, lab coats, and full-body protection. Work with highly potent/hazardous materials and understanding chemical hazards. Work in Class 1 / Div 2 areas and near moving mechanical parts. Operate hand tools, calculators, and weighing/measuring devices.
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Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED