Manufacturing Technician
Manufacturing Technician
Posted on :
25-12-2024
Employer Active
1 Vacancy
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Job Description
Duties:
- Executes fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multiproduct facility.
- Performs duties under limited supervision and according to standard operating and manufacturing procedures.
- Executes independently with adequate training noncomplex 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).
Skills:
- 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.
- 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 computerbased 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.
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
Required Skills:
- DETAIL ORIENTED
- MANUFACTURING TECHNICIAN
- SOP
- CGMP
- SOPS
- Additional Skills:
- OPERATIONS
- STOCKING
- BIOTECHNOLOGY
- BUSINESS INTELLIGENCE
- MAINTENANCE
- FERMENTATION
- SUPPLY CHAIN
- ENTRY LEVEL
- EHS
- SAFETY STANDARDS
- CELL CULTURE
- EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS MANUFACTURING OPERATIONS SIP QUALITY ASSURANCE VOCATIONAL TRAINING ASSEMBLY QUALITY CONTROL
Languages:
English
Minimum Degree Required: Completed High School (Diploma or GED)
Employment Type
Full Time
Key Skills
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