Manufacturing Technician I

Planet Pharma; Fremont (CA); On-site; USD 30,000 - 36,000; Full time

Job summary

Planet Pharma is seeking a motivated entry-level technician to perform foundational downstream manufacturing activities in a multi-product facility. You will handle basic unit operations, materials prep, and kit assembly under supervision, maintaining strict cGMP documentation and safety practices.

The role requires following SOPs, working in a 24/7 shift structure, and collaborating with cross-functional teams to ensure compliant, accurate production support and timely reporting of any

Qualifications

• High school diploma; associates or biotechnology training preferred.
• 1+ years in a cGMP regulated environment is preferable.
• Strong attention to detail and ability to follow SOPs.

Responsibilities

• Perform routine unit operations, cleanse and dispense, weigh and kit assembly.
• Maintain equipment and materials, stock consumables, update controlled SOP binders.
• Document work per cGMP and report abnormalities or deviations; follow safety standards.

Skills

cGMP compliance

SOP adherence

Safety standards

Team collaboration

Shift flexibility

Documentation

Education

High school diploma

Associates/Bachelors in biotechnology preferred

Tools

SOPs knowledge

Computer-based systems

cGMP documentation

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 environment following all applicable 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.

Pay Rate Range: $22-26/hr depending on experience