Downstream Manufacturing Technician

Job Title: Downstream Manufacturing Technician

Job Location: Fremont, CA

Job Type: Contract

Pay Range: $21.28hr - $26.28hr

Job Overview:

The candidate executes fundamental unit operations in downstream manufacturing related to bulk drug substance production in a multi-product facility, adhering to cGMP standards and standard operating procedures.

Responsibilities:

• Executes fundamental unit operations in downstream manufacturing related to the manufacturing of bulk drug substance in a multi-product facility.
• Performs duties under limited supervision and according to standard operating and manufacturing procedures.
• Executes independently with adequate training non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging.
• Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
• Executes with oversight of qualified staff fundamental tasks as CIP and SIP of tanks, manufacturing equipment as well as buffer prep and transfer into tanks and bags.
• Performs daily analytics and maintenance of analytical equipment.
• Executes cleaning and setup of equipment.
• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards, identifies unsafe situations or habits, and escalates appropriately.
• Maintains production areas according to predefined standards (5s).

Skills:

• Works in a highly regulated environment following all applicable SOPs, OCPs, and BGSs for cGMP, EHS, and Compliance policies.
• Focuses on execution of repeatable tasks with moderate technical complexity and performs highly proceduralized tasks.
• Engages in basic interactions with Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, and Quality Control.
• Performs repeatable, highly proceduralized tasks with low to moderate technical impact.

Education and Experience:

• High school degree required; entry-level position.
• Associate or Bachelor s degree or biotechnology vocational training preferred.
• 1+ years of experience in a cGMP regulated industry preferred.
• Ability to concentrate on detail-oriented work in a complex technical setup with a quality and right-the-first-time mindset.
• Strong written and verbal communication skills.
• Ability to work with computer-based systems.
• Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
• Ability to work as part of a high-performing team and collaborate effectively with staff.

== ==

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities