Manufacturing Technician I

Aequor; Fremont (CA); On-site; USD 39,000 - 47,000; Full time

Job summary

Aequor is seeking an entry-level role in downstream manufacturing to perform fundamental unit operations in a multi-product facility. The position requires following SOPs, cGMP regulations, and maintaining accurate documentation. Responsibilities include kit assembly, weigh/dispense, and equipment setup with 2nd shift coverage.

The role emphasizes attention to detail, teamwork, and the ability to work in a highly regulated environment with safety as a priority.

Qualifications

• Experience in a cGMP regulated environment preferred.
• Ability to read and understand SOPs and work instructions.
• Strong attention to detail and right-first-time mindset.
• Proven ability to work in a fast-paced, 24/7 shift environment.

Responsibilities

• Executes fundamental unit operations in downstream manufacturing per SOPs and cGMP.
• Performs duties such as cleaning, weigh/dispense, equipment prep and kit assembly.
• Documents work and reports deviations promptly; maintains clean production areas (5S).
• Supports with stocking, updating SOP binders, and safety compliance.

Skills

Regulatory compliance

SOP adherence

Shift flexibility

Documentation

Education

High school diploma

Associate's or Bachelor's preferred

Job description

Duties

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

Education

High school degree, entry level position. Associates/bachelors degree or biotechnology vocational training preferred.

Preferable Experience

• 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.

Payment Rate

MAX BILL RATE-***/hour