Downstream Manufacturing Technician

Cynet Systems•Fremont, CA

About The Position

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. This is an entry-level position that focuses on the execution of repeatable tasks with moderate technical complexity and performs highly proceduralized tasks. The role involves basic interactions with various departments and requires a quality and right-the-first-time mindset.

Requirements

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.
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.

Nice To Haves

Associate or Bachelor's degree or biotechnology vocational training preferred.
1+ years of experience in a cGMP regulated industry preferred.

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).