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Form of workJob Description
Fully Onsite
Position may work OT and occasional weekends
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.
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.
Requisite Education/Skills:
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
Position may work OT and occasional weekends
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.
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.
Requisite Education/Skills:
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
