Vacancy caducado!
1st shift- 7am-3:30pmPosition Overview: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.Leads or supports in the updating of current or new batch records for current or new processes, initiation of change controls, deviations and the closing of these documents. Leads the training of junior personnel within the large-scale Bioreactor and Media production areas. May include cross training to support other areas including cell culture, clarification, buffer preparation.Responsibilities:
In depth understanding of techniques and processes being executed on routine basis.
Understanding of the BEVS manufacturing Process. Ability to manage and analyze manufacturing data to identify and support changes and improvements.
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 identifing required training and training on, understanding, and following documented procedures which 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)
Follows instructions on notification of deviations as they occur and provides information during investigations.
Other duties as they are required
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
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#GD-SP#LI-SPAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Vacancy caducado!