Manufacturing Technician I

Spectraforce Technologies, Inc.; Fremont (CA); On-site; USD 34,000 - 44,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Manufacturing Technician I to support downstream manufacturing operations at our Fremont, CA facility. This onsite role emphasizes cGMP compliance and teamwork to manufacture bulk drug substances reliably.

The position requires adherence to SOPs, detailed documentation, and safe handling of materials in a regulated environment. Shift availability and accurate execution are essential.

Qualifications

• High school diploma or equivalent; associate/bachelor preferred.
• 1+ years in a cGMP-regulated environment preferred.
• Ability to focus on detail in a complex technical setup with accuracy and safety.
• Strong written and verbal communication skills.
• Ability to read SOPs and work instructions and document work accordingly.

Responsibilities

• Execute fundamental unit operations in downstream manufacturing for bulk drug substance.
• Follow SOPs and manufacturing procedures under limited supervision.
• Prepare, weigh, dispense, and set up equipment; assemble kits and staging.
• Stock consumables and maintain controlled SOP binders; discard expired reagents when needed.
• Perform CIP/SIP operations under staff oversight and monitor analytical equipment.

Skills

Detail-oriented

Communication skills

Teamwork

SOP reading

Computer literacy

Education

High school diploma

Associate/Bachelor's degree preferred

Job description

Position Title

Manufacturing Technician I

Work Location

Fremont, CA 94555

Assignment Duration

6 Months

Work Schedule

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

Work Arrangement

Onsite

Position Summary

• 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.

Key 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 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 appropriately.
• Maintains production areas according to predefined standards (5s).

Qualification & Experience

• Working in a highly regulated environment following all applicable our organization and our organization 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.
• High school degree, entry level position.
• Associates/bachelor's 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 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.