Job Description:
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.
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.