Manufacturing Technician I

Job description

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August! The Manufacturing Technician I is responsible for operating and maintaining processing equipment, preparing components for aseptic and non-aseptic operations, and ensuring compliance with Good Manufacturing Practices (GMP) in a cleanroom environment. The role includes completing or supporting activities such as sanitization of facility, equipment cleaning and assembly, material handling/transferring, formulation, filling, inspection, packaging, and any other Manufacturing operations. ### Responsibilities - Perform routine cleaning and sanitization of production areas to maintain a controlled and compliant environment. - Prepare and transfer materials and components for production using proper sanitization techniques and aseptic handling practices. - Utilize proper aseptic techniques in Grade B/C/D and CNC environments during all tasks. - Adhere to safety and environmental health standards, including proper use of PPE. - Perform Inspection, labeling, and packaging of vials, IV bags, and syringes. - Operate and maintain equipment used across all production processes, including formulation, filling, sterilization, inspection, and packaging with support and oversight from other Manufacturing team members. - Complete all GMP documentation, including batch records, protocols, and deviations, adhering to Good Documentation Practices (GDP). - Collaborate cross-functionally with production, QA, QC, engineering, validation, and maintenance teams as required. - Recognize and report deviations, potential issues, or equipment malfunctions to the management team. - Load, operate, and unload sterilization equipment, such as autoclaves, terminal sterilizer, and HEPA transfer carts. - Maintain consistent presence on Manufacturing floor and support all teams in production as needed. - Assist with dispensing and formulating raw materials for aqueous and non-aqueous products, ensuring accuracy and compliance with batch records. - Assist with set up and operate filling lines and associated equipment, including mixers, tanks, pumps, autoclaves, and HEPA transfer carts. - Assist with preparing equipment for use using sterilization equipment such as autoclaves and HEPA cabinets. ### Requirements - High School Diploma or equivalent required. An associate degree in a technical field or a bachelor's degree in biological, chemical sciences, or engineering preferred but not required. - Experience regulated manufacturing environments, pharmaceutical preferred. - Mechanical aptitude to operate and troubleshoot a variety of equipment and instruments. - Understanding of GMP and GDP standards. - Strong attention to detail, with the ability to follow SOPs, complete documentation tasks accurately. - Basic computer skills and familiarity with technical documentation. - Mathematical skills for measurements and calculations (e.g., volume, weight). - Physical ability to raise arms over head, stoop, stand, climb, and lift 30-50 lbs. - Effective verbal and written communication skills. - Prolonged periods of standing, walking, or working in a cleanroom environment. - Ability to wear fully protective gowning for extended periods. - Must be able to lift and transport materials weighing up to 50 lbs. - Ability to arrive at work consistently for assigned shifts. ### Shift Differential Opportunity - We have three shifts available: - 1st shift - 7:00am - 3:30pm (Monday - Friday) - 2nd Shift - 3:00pm - 11:30pm (Monday - Friday) - 3rd shift: 11:00pm - 7:30am (Sunday - Thursday) - 2nd shift Technicians are given the opportunity to receive an extra $2/hour worked on 2nd shift - 3rd shift Technicians are given the opportunity to receive an extra $3/hour worked on 3rd shift. - Upon qualification in the above above functions, Technicians will be given the opportunity to cross train in filling operations, formulation and component preparation, packaging operations, and inspection.