We are seeking a highly motivated and detail-oriented Cell Culture Manufacturing Technician to join our cGMP commercial manufacturing facility. In this role, you will be responsible for the execution of standard operating procedures (SOPs) and batch records in the production of Flublok Drug Substance within the dedicated Cell Culture area, focusing on cell maintenance and virus stock generation.
location: Pearl River, New York
job type: Contract
salary: $24.00 - 26.56 per hour
work hours: 7 to 3
education: High School
responsibilities:
- Execute aseptic cell culture techniques, including sampling, analysis, cell splitting, and virus stock preparation in flasks and bioreactors.
- Perform cell scale-up to bioreactors for protein production.
- Set up, operate, and maintain 100L single-use bioreactors (SUBs).
- Perform cleaning and preparation of workspaces and biosafety cabinets.
- Conduct preventive maintenance and changeovers for area equipment, including biosafety cabinets, shaker incubators, tabletop centrifuges, and SUBs.
- Perform aseptic sampling and environmental monitoring.
- Analyze cell culture samples using cell counters and microscopes for contamination checks.
- Maintain accurate and compliant documentation (GDP).
- Participate in cGMP training and adhere to all safety protocols.
- Assist in troubleshooting manufacturing issues and participate in investigations.
- Contribute to the cleaning and maintenance of the cGMP facility.
- Adhere to material, personnel, and equipment flow SOPs.
- Work a flexible schedule, including weekends and holidays as needed.
- Assist with deviation and CAPA management.
- Potentially cross-train and operate in flex areas.
qualifications:
Required Skill-Sets:
- High school diploma or equivalent with at least 2 years of work experience or training in a cGMP manufacturing environment.
- Proficiency in aseptic technique.
- Experience with cell culture maintenance and scale-up.
- Ability to operate and maintain laboratory equipment, including biosafety cabinets, incubators, centrifuges, and bioreactors.
- Strong understanding of cGMP and GDP principles.
- Ability to follow SOPs and batch records.
- Excellent documentation skills.
- Strong communication and interpersonal skills.
- Ability to analyze manufacturing data.
- Fluent in English, both written and spoken.
- Experience with 100L single-use bioreactors (SUBs).
- Knowledge of the Baculovirus Expression Vector System (BEVS) manufacturing process.
- Experience with cell analysis and data interpretation.
- Experience with environmental monitoring.
- Experience with preventative maintenance of equipment.
- Experience with deviation and CAPA management.
skills: SOP, MS-WORD, CAPA, MS-EXCEL, MS-Powerpoint, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
