Manufacturing Associate 2, Upstream/Downstream
About The Position
The Manufacturing Associate 2 supports operational readiness and biopharmaceutical manufacturing activities in a cGMP environment. The role assists with project-phase readiness and steady-state operations at a 24/7 facility, helping maintain safe, consistent, and efficient production. Flexibility to work shifts and rotating schedules, including weekends and nights, is required. Responsibilities include assisting with procedure review, document preparation, testing, commissioning, and equipment readiness; executing and documenting assigned manufacturing processing and support activities according to SOPs and cGMP requirements; and performing process monitoring and in-process testing such as pH, conductivity, and visual inspections. The associate follows technical instructions, maintains accurate documentation, completes required training and qualifications, collaborates with experienced associates, technical staff, and supervisors, and follows safety, quality, and operational procedures. Other duties may be assigned. The position requires a high school diploma or GED and at least two years of related experience, including two or more years of direct experience in a cGMP manufacturing environment, or an equivalent combination of education and experience. An associate degree in Life Sciences or a related field, qualification in a support area, and BioWorks or BTEC Capstone cGMP coursework are preferred.
Requirements
- High school diploma or GED and two years of related experience, or an equivalent combination of education and experience.
- At least two years of direct experience in a cGMP manufacturing environment.
- Knowledge of support process equipment and understanding of cGMPs, safety, and operational procedures.
- Ability to perform operations and document them accurately, and to follow technical instructions.
- Strong verbal and written communication skills and ability to work effectively in a team.
- Ability to adapt in a fast-paced, changing environment.
- Willingness and flexibility to work shifts in a 24/7 environment, including weekends and nights.
- Ability to discern verbal cues.
- Ability to sit and stand for prolonged periods.
- Ability to work at heights greater than four feet and ascend or descend ladders, scaffolding, ramps, or similar structures.
- Ability to move objects up to 33 pounds.
- Ability to perform repetitive tasks using wrists, hands, or fingers; bend, push or pull, reach for materials 18 to 60 inches high, and use twisting motions.
- Ability to work in environments that may require respiratory protection and, in mechanical or production spaces, hearing protection and enrollment in a hearing conservation program.
Nice To Haves
- Associate degree in Life Sciences or a related field.
- Qualification in a support area, such as Formulation Buffer Prep, Media Prep, or DSM Buffer Prep, through internal or post-hire training.
- BioWorks or BTEC Capstone cGMP coursework.
Responsibilities
- Support operational-readiness activities for biopharmaceutical manufacturing.
- Assist with procedure review, document preparation, testing, commissioning, and equipment-readiness activities.
- Execute and document assigned manufacturing processing and support activities according to SOPs and cGMP requirements.
- Perform process monitoring and in-process testing, such as pH, conductivity, and visual inspections.
- Follow technical instructions and accurately document completed work.
- Complete and maintain required training and qualifications.
- Work collaboratively with experienced associates, technical staff, and supervisors.
- Follow safety, quality, and operational procedures.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
