Primary responsibility is large scale recombinant protein production operations for commercial production through execution of SOPs, Batch Records, and all associated cGMP activities in the manufacturing facility. Duties include operation, maintenance, cleaning (CIP) and sterilization (SIP) of large scale cell culture bioreactors and associated operations such as media preparation, infection and harvest. The incumbent is capable of identifying, troubleshooting and leading the resolution of operational and equipment problems as they arise in the large-scale Bioreactor and Media Preparation areas with minimum supervision and effective communication to management.
location: Pearl River, New York
job type: Contract
salary: $32.00 - 37.66 per hour
work hours: 7 to 3
education: Bachelors
responsibilities:
- Interacts with other departmental personnel to assist in resolving manufacturing quality issues.
Ability to present and explain techniques and results of manufacturing processes with outside departmental personnel. - Responsible for identifying required training and training on, understanding, and following documented procedures that apply to their departments that support the Quality System.
- Maintains records and documentation in accordance with a cGMP environment and improves as necessary.
- Participates in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.
- Cross training as a support operator as required.
- 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 (estimated ≥1 weekend per month). Potential to switch to second shift or weekend shift.
- Follows instructions on notification of deviations as they occur and provides information during investigations.
qualifications:
- Education: High School degree with at least seven of experience or training in a cGMP manufacturing environment OR BS degree with three years of experience OR MS degree with one year of experience
- Knowledge of cGMP
- English fluent, both written and spoken
- Good communication and social skills
- Minimum HS Diploma
- Minimum of 4+ years of experience
- GMP manufacturing environment
- Pharma Experience is required
- Experience with bioreactors, fermenters, and automated control systems
- Cytiva & Allen Bradley (or similar automation exp) - Strong communication skills, ability to work cross-functionally as a team
- Bioreactor & cell culture experience
- More than 4 years of experience
skills: SOP, MS-WORD, MS-EXCEL, Cell Cultures, 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.
