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The Manufacturing Associate supports the production of therapeutic proteins (API) in a cGMP regulated clean room environment. The role involves executing process steps, operating equipment, performing basic lab tasks, maintaining facility cleanliness, and following SOPs and GMP/GDP guidelines.

Responsibilities:

Execute manufacturing process steps and follow SOPs, batch records, and GMP/GDP guidelines. Set up, operate, and monitor equipment including CIP/SIP systems.

Perform basic lab tasks:

pH, conductivity checks, sampling, and product testing.

Handle material movements:

raw materials, chemicals, and components. Maintain equipment and facility through routine cleaning and sanitization (6S support). Demonstrate aseptic technique and work in clean room gowning conditions. Complete required training and maintain qualification for assigned tasks. Participate in shift handovers, meetings, emails, and project activities. Perform other duties as assigned.

Requirements:

Associate degree in Life Sciences (Biology, Biotech, Chemistry, Microbiology) preferred. OR relevant manufacturing/technical experience.

Mandatory Skills:

Ability to follow SOPs, GMP, GDP, and safety guidelines. Basic lab skills (pH, conductivity, sampling). Ability to work in clean room gowning environment. Computer literacy (automated systems, electronic documentation). Strong attention to detail and documentation accuracy. Willingness to work shifts and perform physical tasks.

Experience Required:

Preferred backgrounds that have shown success: Food service / cooks (recipe following). Pharmacy technicians. Mechanical aptitude / robotics. EMTs / nurses / nurse aides. Tech support / computer skilled candidates. Security guards. Sig Sauer / regulated industry workers. Anyone with experience following SOPs, guidelines, or industry regulations. Manufacturing or scientific coursework is a strong plus.