DEPARTMENT DESCRIPTION: This is an aseptic fill/finish operation.
Perform manufacturing operations with the need to be able to direct lower level personnel and maintain operations on a daily basis
Operate complex systems and equipment under minimal supervision in strict accordance with current GMP's, SOP's, and safety guidelines.
Perform and/or direct preliminary troubleshooting activities. Solicit direction from senior personnel as needed.
Train less experienced or new staff on new procedures.
May provide work direction to lower-level staff.
Author new procedures of moderate complexity as well as revise current procedures.
Strong attention to detail, and excellent communication skills.
Perform operations in the aseptic filling areas while maintaining the integrity and cleanliness of these areas by utilizing aseptic gowning requirements and techniques.
Assist with deviation investigations.
* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
High School diploma/GED with 3-5 years of experience in a cGXP environment, or a Bachelor’s degree with 1-3 years of experience in a cGXP environment. This includes a strong knowledge of aseptic gowning, aseptic processing, and proper aseptic techniques.
Experience in Aseptic Fill/Finish operations strongly preferred
Prior aseptic gowning and processing techniques is desirable
Familiar with deviations. CAPA's and change control
Familiar with ERP systems
Familiar with operations of Autoclaves
SPECIAL WORKING CONDITIONS:
This position also requires strong manual dexterity and physical demands of lifting up to 30 pounds.
Must be willing to work weekends or required to work overtime to meet production demands.
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.
At 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.
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