Sanofi Group Manufacturing Specialist III in Framingham, Massachusetts
**Project-based work that requires an individual that is flexible to work overtime as needed and agility to balance multiple tasks
**Excellent opportunity to work in cross-functional teams including Engineering, Validation, QC, QA, Facilities, Metrology, and MSAT.
*High-profile position with the autonomy to run investigations*
*Experience with navigating through electronic equipment *
*New product project work*
Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 large scale therapeutic protein manufacturing facility.
This is a 1st shift position in a new large scale cGMP biologics facility which includes solution preparation, equipment preparation, upstream operations, and downstream operations. Initial job responsibilities will include developing electronic Batch Production Records, manufacturing procedures and training materials and training personnel during plant start-up from Operational Commissioning/Shakedown through Process Validation (PV) and commercial operations.
The primary job function post PV runs will be to use expert knowledge of compliance and GXP manufacturing to lead deviation investigations and manage CAPA implementation, partner with direct manufacturing staff for enhancing and improving the manufacturing instruction set, oversee and support manufacturing’s training program, and identify and manage continuous improvement initiatives.
Maintains a safe working environment and reporting incidents/accidents to site leadership.
Manages cross functional teams to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventive Action Plan
Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.
Conducts complex document revisions and/or document management including electronic batch production records, manufacturing procedures and cross functional procedures.
Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory and compliance.
Schedules and/or delivers training to manufacturing personnel in accordance with Department Training Plan to ensure staff can perform manufacturing operations correctly, safely and compliantly
Leads cross functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology and Manufacturing Science and Technology and implement effective Change Controls.
Partners with Manufacturing Managers and Quality to ensure manufacturing areas are inspection ready at all times.
Performs routine documentation assessments to ensure alignment between SOP's, electronic Batch Records, Equipment Logs and Automated systems. Revises as necessary.
Manages or supports plant floor continuous improvement initiatives.
Represents Manufacturing in Project Team meetings; may lead department initiatives and projects.
Collaborates with scheduling, facilities, metrology, materials logistics coordinator and manufacturing to manage and schedule work orders, maintenance of small equipment, adequate stocking of supplies.
High School diploma/GED or Biotech Certificate with 7-10 years of experience in a cGXP manufacturing environment, or a Bachelor’s degree with 5-8 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 2 year experience with deviation or investigation management systems.
Excellent written and oral English language skills
Bachelor’s degree in Biology, Chemistry, Biochemistry or Chemical Engineering.
Demonstrated ability to lead cross functional teams and facilitate team meetings
Experience authoring and reviewing standard operating procedures, on-the-job-trainings, electronic batch records and other controlled documents.
Familiarity with Deviation Management and Change Control Systems
Experience in troubleshooting, investigation, and root cause analysis in a GXP environment
SPECIAL WORKING CONDITIONS:
- Ability to gown and gain entry to 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.