**Monday- Friday- 1st shift position. Weekends and holidays as per business needs**
**Strong experience in deviation and change control**
**Working with cross-functional teams**
The Principle Manufacturing Specialist uses expert knowledge of compliance and GXP manufacturing processes to manage critical investigations, major improvement initiatives, and site-wide projects within biologics and/or biosurgery.
Practices and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines.
Manages cross-functional teams to drive timely, complex investigation closure, determine root cause and implement appropriate corrective and preventative actions.
Takes an active role in deviation reduction and/or continuous improvement with a right-first-time mentality.
Utilizes subject matter expertise and investigation skills to identify and resolve manufacturing issues, improve process operations and affect positive change.
Initiates, designs, and implements changes to electronic master and batch production records.
Works with team to perform multiple complex document revisions and tasks to ensure timely completion of investigations, corrective actions, or major projects.
Ability to delegate, level-load assignments, and attend meetings in the absence of management.
Develops new Manufacturing Specialists.
Makes decisions and defines objectives and prioritization of assignments independently.
Works independently with minimal supervision and direction.
Leads cross-functional continuous improvement efforts in partership with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, Manufacturing Sciences and Technology, and Information Technology.
Expertly utilizes Microsoft office applications.
Creates and presents trending and metrics reports.
Provides direction to the Manufacturing Specialist in the absence of the operations manager.
*Core/Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
HS/GED or equivalent with 10-12 years' of experience in cGXP manufacturing environment--or--Bachelor’s degree with 8-10 years' of experience.
Subject matter expertise in biologics manufacturing.
Knowledge and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing operations.
Minimum of 5 years’ experience with deviation and/or change management systems.
Demonstrated ability to lead cross functional teams and facilitate team meetings.
Excellent written and oral English language skills.
Bachelor’s degree in Biology, Chemistry, Biochemistry, Chemical Engineering.
Demonstrated ability to implement robust cost- or time-savings projects.
Experience with electronic manufacturing execution systems, system interfaces, and periferals.
Experience authoring and reviewing standard operating procedures, on-the-job-trainings and other controlled documents.
Experience in troubleshooting, investigation and root cause analysis in a GXP environment.
Special Working Conditions
Ability to gown and gain entry to classified manufacturing areas.
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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