Manufacturing Technician

About This Role

This role involves executing fundamental unit operations in downstream manufacturing for bulk drug substance in a multi-product facility. The Manufacturing Technician performs duties under limited supervision, following standard operating and manufacturing procedures, and maintaining production areas to predefined standards.

Responsibilities

• Execute independently non-complex fundamental operations such as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging
• Perform internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies
• Execute with oversight of qualified staff fundamental tasks such as CIP and SIP of tanks and manufacturing equipment, as well as buffer prep and transfer into tanks and bags
• Perform daily analytics and maintenance of analytical equipment
• Clean and set up equipment
• Document work according to cGMP and cGDP
• Adhere to established regulations and follow cGMP established by site
• Report abnormalities and deviations in a timely and accurate manner
• Adhere to safety standards and identify unsafe situations/habits and escalate appropriately
• Maintain production areas according to predefined standards (5s)

Requirements

• High school degree
• Ability to work in a highly regulated environment following all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies
• Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice
• 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 have:

• Associates/bachelor's degree or biotechnology vocational training
• 1 or more years of experience in cGMP regulated industry

Important Details

• Schedule: 2nd Shift: Sunday-Wednesday, Sunday-Tuesday (3:00 PM-1:30 AM), Wednesday (3:00 PM-11:30 PM)
• Contract: 6 months

About the Company

This role involves basic interactions with Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, and Quality Control teams.