Manufacturing Associate

Manufacturing Support Associate Department:
Manufacturing Operations

Location:

Tustin, CA Industry: Biopharmaceutical Manufacturing

Reports To:

Manufacturing Supervisor/Manager Position Summary The Manufacturing Support Associate provides operational support for biopharmaceutical manufacturing operations by ensuring equipment, materials, documentation, and cleanroom environments are prepared for GMP production. This position supports upstream, downstream, and fill-finish manufacturing activities while maintaining compliance with cGMP, FDA regulations, company quality standards, and safety requirements.

Essential Duties and Responsibilities Support daily manufacturing operations in a GMP-regulated environment. Prepare, stage, and verify raw materials, buffers, media, and production supplies. Assemble, clean, sterilize, and maintain manufacturing equipment and single-use systems. Perform equipment setup, line clearance, and changeover activities. Execute cleaning, sanitization, and environmental monitoring procedures. Complete batch production records, equipment logbooks, electronic records, and other manufacturing documentation accurately and in real time.

Follow cGMP, SOPs, Good Documentation Practices (GDP), FDA regulations, OSHA requirements, and company safety policies. Monitor inventory levels of manufacturing materials and coordinate replenishment with warehouse personnel. Assist with deviation investigations, CAPAs, change controls, and root cause analyses. Support equipment qualification, process validation, and continuous improvement initiatives. Collaborate with Manufacturing, Quality Assurance (QA), Quality Control (QC), Maintenance, Facilities, Validation, and MSAT teams to meet production schedules.

Maintain cleanroom organization and follow aseptic gowning procedures. Participate in shift handoffs and communicate production status, issues, and material needs effectively. Maintain a clean, organized, and safe manufacturing environment. Qualifications Bachelor's degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, Microbiology, or a related scientific discipline. 0–3 years of experience in pharmaceutical, biotechnology, medical device, or GMP manufacturing environments preferred. Experience working in clean rooms or laboratory environments is a plus.

Strong documentation, organizational, and attention-to-detail skills. Excellent communication and teamwork abilities. Ability to follow detailed SOPs and work effectively in a regulated manufacturing environment. Ability to work flexible shifts, weekends, or overtime as production demands require. Technical Skills Current Good Manufacturing Practices (cGMP) Good Documentation Practices (GDP) Standard Operating Procedures (SOPs) Batch Production Records (BPR) Aseptic technique Cleanroom operations Buffer and media preparation Single-use bioprocess systems Equipment cleaning and sanitization Autoclave operation Manufacturing Execution Systems (MES) Electronic Batch Records (E ) SAP or ERP systems preferred Microsoft Office Suite

Physical Requirements Ability to lift up to 40 pounds. Ability to stand, walk, bend, reach, and perform repetitive tasks throughout the shift. Ability to work in a cleanroom environment and wear required PPE, including gowns, gloves, masks, and safety equipment, for extended periods. Ability to work around manufacturing equipment and follow all applicable safety procedures. Schedule This position may require flexible scheduling, weekends, overtime, and/or alternative shifts based on manufacturing and production requirements.

Why Join Us? This is an excellent opportunity for a science graduate or early-career professional to gain hands-on experience in biopharmaceutical manufacturing, GMP operations, cleanroom processes, and regulated production environments while working alongside Manufacturing, Quality, Engineering, and Technical Operations teams.