**Strong technical writing skills, experience with deviations, CAPA's, and change control**
**Leads cross-functional teams including working with Engineering, Validation, QA, QC, Facilities, Metrology, and MSAT**
Manufacturing Operations is responsible for supporting the Biosurgery Manufacturing APU. Operation's main functions are leading deviation investigations and managing CAPA implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing and supporting manufacturing's training program, and identifying and managing continuous improvement initiatives.
Job Overview with Key Responsibilities
The Manufacturing Specialist II uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.
Practices safe work habits and adheres to Sanofi's safety procedures and guidelines.
Participates on cross functional teams to drive investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive changes.
Conducts document revisions and/or document management including batch production records and manufacturing procedures.
Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance.
Performs training with staff on the floor, as needed.
Trains new Manufacturing Specialists
Organizes and participates on cross-functional continuous improvement teams with engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.
Works independently with minimal supervision and direction.
Participates in determining objectives of assignment.
Performs work that consistently requires independent decision making and exercise of independent judgment and discretion
Effectively utilizes Microsoft office applications
Creates and presents trending and metrics reports.
*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 or Biotech Certification with 5-7 years of experience in cGXP manufacturing environment, or Bachelor's degree with 3-5 years of experience.
Demonstrated knowledge/understanding of biologic manufacturing.
Knowledge and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing operations.
Excellent written and oral English language skills.
Bachelor's degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.
Ability to influence in a cross-functional environment.
Experience facilitating meetings.
Experience authoring and reviewing standard operating procedures, on-the-job trainings, and other controlled documents.
Familiarity with Deviation Management Systems
Experience in troubleshooting, investigation, and root cause analysis in a GXP environment.
Minimum of 2 years' experience with deviation or investigation management systems.
Special Working Conditions
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.