Manufacturing Technician I

Lancesoft; Fremont (CA); On-site; USD 48,000 - 64,000; Full time

Job summary

Lancesoft is hiring for an entry-level Manufacturing Technician in Fremont, CA to execute fundamental unit operations in downstream manufacturing for bulk drug substance in a multi-product facility. Tasks are performed under limited supervision following cGMP and cGDP procedures and site SOPs.

This role requires strong attention to detail, basic math, and good written/verbal communication. Education: high school diploma; associates/bachelors preferred.

Qualifications

• High school degree; associates/bachelors preferred.
• 1+ year experience in a cGMP regulated industry preferred.
• Ability to follow SOPs and cGMP standards.

Responsibilities

• Executes fundamental unit operations in downstream manufacturing for bulk drug substance.
• Performs tasks such as cleaning, weigh/dispense, kit assembly, and equipment prep.
• Documents work per cGMP and reports anomalies.
• Maintains production areas to 5S and safety standards.

Skills

cGMP compliance

Documentation

Equipment operation

Safety awareness

Teamwork

Education

High school diploma

Associates/Bachelor's in biotech (preferred)

Tools

SOPs knowledge

Computer literacy

Job description

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, manufactruing equipment as well as buffer prep and transfer into tanks and bags Daily analytics and maintenance of analytical equipment. 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 and identifies unsafe situations / habits and escalates approriately. Maintains production areas according to predefined standards (5s).

Skills:

Working in a highly regulated enviroment 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. Low to moderate - strong focus on execution of repeatable tasks with moderate technical complexity. Performing highly proceduralized tasks. Basic interactions Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control Does not require extensive technical knowledge of manufacturing operations. Low impact, repeatable, highly proceduralized.

Education:

High school degree, entry level position. Associates/bachelors degree or biotechnology vocational training preferred. Preferable 1 or more years of experience in cGMP regulated industry -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 intructions 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.

Schedule Notes:

2nd Shift: Sun-Wed. Sun-Tues (3PM-1: 30AM), Wed (3PM-11: 30PM). Total 38 hours/week.