**12-hour day shift positions- including rotating holidays, weekends, and overtime as per business needs**
This is a 12-hour, rotating position in a flexible, single-use technology, large-scale cGMP biologics facility. Initial job responsibilities will include leading a team responsible for a diverse range of manufacturing-related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) and commercial operations. The Sr. Manufacturing Associate will be responsible for performing a variety of complex tasks under the general guidance and in accordance with the manufacturing instruction set and current GMPs.
Maintains a safe working environment and reporting of incidents/accidents to Manufacturing management.
Effectively demonstrates an understanding of GMPs and how they apply to specific responsibilities.
Follows verbal and written procedures in operating production and equipment and performing processing steps; accurately completes appropriate production documentation.
Maintains cleanliness and orderliness in the process area
Ensures the production area is stocked with supplies.
Performs batch record review, EWI (Electronic Work Instruction) revisions, and work order generation.
Fulfills the role of the lead trainer on numerous operations and is an area SME.
Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MSIT, Validation, etc.
Utilizes manufacturing knowledge to improve process operations and affect positive change.
Demonstrates ability to troubleshoot basic mechanical operations.
Effectively utilizes Microsoft Office applications.
Mentors are less experienced operators.
Fulfills the role of Team Lead in the absence of the Team Supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings, and providing technical support as needed.
May be asked to represent the organization at meetings such as shift scheduling meetings, +QDCI, deviation review meetings, and project meetings.
Escalates production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to Manufacturing management and/or appropriate functional area(s).
Cross-train manufacturing personnel.
Performs in-process analytical testing.
Demonstrates proficient knowledge of automation systems (INFOR, MES, ERP, DeltaV).
Demonstrates general knowledge and practice of aseptic techniques.
Contributes to continual improvement of all manufacturing documentation (SOPs, EWI’s, MBRs, OJTs) to ensure they are current, accurate, and clear.
Supports plant floor continuous improvement initiatives.
*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 5-7 years of experience in a cGXP environment, or a Bachelor’s degree with 3-5 years of experience.
Must have prior experience in cGMP manufacturing operations.
Bachelor’s degree with 4-6 years of experience in bulk biologics GMP manufacturing.
Effectively uses process automation systems to operate production processes (i.e. Delta V).
Experienced reviewing and creating controlled documents.
Familiarity with deviation management systems (i.e. Phenix).
SPECIAL WORKING CONDITIONS:
Ability to lift up to 50 lbs.
Ability to stand on average 10 hours per shift.
Ability to gown and gain entry to manufacturing areas.
Ability to work a twelve-hour rotating shift and every other weekend, including holidays as scheduled.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.