Primary responsibility of the incumbent will be operation of general manufacturing equipment under close supervision in accordance with current relevant quality standards or standardized procedures and within safety guidelines in the production of Flublok Drug Substance in the media, buffer and solution preparation areas of the cGMP commercial manufacturing facility. Requires good documentation skills and attention to detail. Duties will include the operation, maintenance, cleaning and sanitization of media and buffer equipment such as stainless-steel mix tanks including transfer lines, standalone mixing units, use of water-for-injection (WFI) point of use taps. Other duties will include the cleaning and preparation of workspaces and biosafety cabinets. The incumbent should be proficient in aseptic technique, preventive maintenance, and changeovers for area equipment, including biosafety cabinets, magnetic mixers, in-process testing equipment (pH / conductivity meters and osmometers). Secondary responsibilities will be to aid in the troubleshooting of problems as they arise in the media, buffer and solution preparation areas. Business needs may also require cross training and operations in flex areas.
location: Pearl River, New York
job type: Contract
salary: $20 - 26 per hour
work hours: 7 to 3
education: High School
responsibilities:
Job Responsibilities
- In depth understanding of techniques and processes being executed on routine basis.
- Responsible for all aspects of media, buffer and solution formulation including equipment preparation (CIP and SIP), appropriate use of raw materials and components (FIFO), weighing and dispensing of raw materials and intermediate solutions, material sampling for applicable analytical testing, filter integrity testing, etc.
- Responsible for the operation and maintenance of ancillary equipment such as pH / conductivity meters, osmometer, tube welder, tube sealer, peristaltic pumps, etc.
- Interacts with other departmental personnel to assist in resolving manufacturing quality issues.
- Technician should have the ability to manage and analyze manufacturing data.
- Ensure good documentation practices (GDP) in execution and reviews of production records.
- Responsible for all required cGMP training including additional training assigned by their manager.
- Participates in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.
- Follows established SOPs for the flow of materials, personnel, and equipment in and out of the cGMP facility.
- Work a flexible work schedule, weekends and holidays as required, and as needed by department.
- Work with Compliance regarding notification of deviations and CAPAs as they occur and provides information during investigations.
- Other duties as they are required.
qualifications:
Required Qualifications
- High School degree with at least 2 years of work experience, or training within a cGMP manufacturing environment
- General knowledge of cGMP, GDP, SOP's
- Good communication and social skills
- Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desired but not required
skills: SOP, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP)
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
