What are the responsibilities and job description for the Manufacturing Technician I position at LanceSoft, Inc.?
Title: Manufacturing Technician I
Location: Fremont, CA, 94555
Duration: 12 Months
SHIFT: 1st Shift: Mon, Tues, Wed, Sun, 6:00AM-4:30PM
Duties
Location: Fremont, CA, 94555
Duration: 12 Months
SHIFT: 1st Shift: Mon, Tues, Wed, Sun, 6:00AM-4:30PM
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, 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, identifies unsafe situations / habits, and escalates appropriately.
- Maintains production areas according to predefined standards (5s).
- Working 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.
- 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 instruction 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.
- MANUFACTURING TECHNICIAN
- SOP
- CGMP
- SOPS
- DETAIL ORIENTED
- MANUFACTURING OPERATIONS
- SIP
- OPERATIONS
- STOCKING
- BIOTECHNOLOGY
- BUSINESS INTELLIGENCE
- MAINTENANCE
- FERMENTATION
- SUPPLY CHAINENTRY LEVEL
- EHS
- SAFETY STANDARD
- SCELL CULTURE
- EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
- QUALITY ASSURANCE
- ASSEMBLY
- QUALITY CONTROL
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