Job Tittle: Manufacturing Technician
Job ID: 37188275
Location: Fremont, CA
Duration: 6-12 Months
Role Overview
The Manufacturing Technician I will support downstream manufacturing operations for bulk drug substance production in a multi-product facility. This is an entry-level role with responsibilities performed under limited supervision, following cGMP and cGDP standards.
Key Responsibilities
- Execute fundamental operations: parts cleaning, weigh and dispense, equipment prep, kit assembly, staging.
- Perform support duties: stocking consumables, updating SOP binders, discarding expired reagents, reporting anomalies.
- Assist with CIP/SIP of tanks and equipment, buffer preparation, and transfers.
- Conduct daily analytics and maintain analytical equipment.
- Clean and set up manufacturing equipment.
- Document work accurately per cGMP/cGDP standards.
- Adhere to safety standards, report deviations, and maintain production areas per 5S.
Required Skills
- Ability to work in a highly regulated environment (BI SOPs, OCPs, BGSs).
- Flexibility to work within a 24/7 shift structure.
- Strong focus on repeatable, proceduralized tasks with moderate technical complexity.
- Basic interactions with Cell Culture, Purification, Compliance, Engineering & Technology, Supply Chain, QA, and QC.
- Detail-oriented with strong adherence to quality standards.
Education & Experience
- High school diploma required; Associate’s/Bachelor’s degree or biotechnology vocational training preferred.
- At least 1 year of experience in a cGMP-regulated industry preferred.
- Strong written and verbal communication skills.
- Ability to work with computer-based systems.
- Ability to read and understand SOPs and document work accurately.
- Team-oriented with effective collaboration skills.
