Manufacturing/ Production Technician/ Downstream Processing Technician

Job Title: Manufacturing Technician
Location: Los Angeles, CA

Work Environment: Cleanroom / Biologics Manufacturing
Industry: Pharmaceutical / Biopharmaceutical Manufacturing

Job Summary:
We are seeking a detail-oriented Manufacturing Technician Albumin Bulk to support the manufacturing of plasma-derived injectable protein therapies. The technician will be responsible for setting up, operating, monitoring, and cleaning manufacturing equipment used in the separation, purification, filling, inspection, and packaging of pharmaceutical products.

The ideal candidate will follow FDA regulations, Good Manufacturing Practices (GMP), safety guidelines, and established standard operating procedures (SOPs) while maintaining accurate production documentation in a cleanroom environment.

Key Responsibilities:

• Set up, operate, monitor, and clean manufacturing equipment used in biologics and plasma-derived pharmaceutical processing.

• Support the production of albumin and other injectable protein therapies through established manufacturing procedures.

• Operate equipment such as ultrafiltration (UF) units, chromatography columns, centrifuges, Clean-In-Place (CIP) systems, and Steam-In-Place (SIP) systems.

• Perform routine process measurements, including pH, refractive index, turbidity, and conductivity testing.

• Operate touch-screen Operator Interface Terminals (OITs) to monitor and control manufacturing processes.

• Perform equipment and facility cleaning in accordance with approved cleaning procedures.

• Work in a sanitized cleanroom environment while following aseptic manufacturing and gowning requirements.

• Maintain accurate batch records, production logs, and other required documentation in compliance with FDA regulations and company procedures.

• Follow GMP requirements, SOPs, departmental safety policies, and applicable quality standards.

• Handle chemicals and manufacturing materials safely while adhering to established protocols.

• Collaborate with production, quality, and other manufacturing teams to meet production schedules and operational targets.

• Maintain a clean, safe, and organized manufacturing environment.

Required Qualifications:

• High school diploma or GED required.

• Strong attention to detail and commitment to quality and compliance.

• Ability to read, write, and communicate effectively in English.

• Basic computer skills and proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.

• Ability to follow written procedures, maintain accurate documentation, and complete tasks within established deadlines.

• Strong work ethic, problem-solving skills, and ability to work effectively in a team environment.

• Ability to prioritize multiple tasks and exercise sound judgment.

• Flexibility to work different shifts as needed to support 24/7 manufacturing operations.

• Ability to comply with cleanroom gowning, hygiene, and safety requirements.

Preferred Qualifications:

• Associate degree, relevant technical certification, or military experience.

• Previous experience in pharmaceutical, biopharmaceutical, biotechnology, or biologics manufacturing.

• Experience working in a cleanroom or aseptic manufacturing environment.

• Knowledge of Good Manufacturing Practices (GMP), FDA regulations, and SOPs.

• Experience operating pharmaceutical process equipment, including UF systems, chromatography columns, centrifuges, CIP, and SIP systems.

• Experience with batch records, manufacturing documentation, and quality procedures.

• Familiarity with basic laboratory or process measurements, such as pH, conductivity, turbidity, and refractive index.

Physical Requirements and Work Environment:

• Ability to lift and move materials weighing up to 50 pounds.

• Ability to stand for extended periods, including up to four hours at a time.

• Manual dexterity to operate manufacturing equipment and perform production tasks.

• Ability to wear required cleanroom garments and work in an aseptic or sanitized environment.

• Ability to work around approved manufacturing chemicals, potentially hazardous substances, and biological materials while following required safety precautions.

• Ability to work in a regulated pharmaceutical manufacturing facility.