We are looking for Downstream Manufacturing Technician for our client in Fremont, CA
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.
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Benefits
Our Benefits Include:
- 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
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.
