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Manufacturing Associate - Night Shift

Company: Sanofi Group
Location: Framingham
Posted on: September 20, 2022

Job Description:

**POSITION OVERVIEW**

This is a 7p-7a, 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 Manufacturing Associate will be responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

**CORE RESPONSIBILITIES:**

+ Maintains a safe working environment and reporting of incidents/accidents to Manufacturing management.

+ Effectively demonstrates 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 process area.

+ Ensures production area is stocked with supplies.

+ Performs batch record review, EWI (Electronic Work Instruction) revisions, and work order generation. --- 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 less experienced operators.

+ Fulfills the role of Team Lead in the absence of the Manufacturing Sr. Associate.

+ 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).

+ Performs in process analytical testing.

+ Demonstrates general knowledge of automation systems (INFOR, MES, ERP, DeltaV).

+ Demonstrates general knowledge and practice of aseptic techniques.

**ADDITIONAL RESPONSIBILITIES:**

+ Cross train manufacturing personnel

**CONTINUOUS IMPROVEMENT:**

+ Contributes to continual improvement of all manufacturing documentation (SOP's, EWI's, MBR's, OJT's) to ensure they are current, accurate, and clear.

+ Supports plant floor continuous improvement initiatives.

**BASIC QUALIFICATIONS:**

+ 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.

+ Must have prior experience in cGMP manufacturing operations.

**PREFERRED QUALIFICATIONS:**

+ Bachelor's degree with 2-4 years of experience in bulk biologics GMP manufacturing.

+ Effectively uses process automation systems to operate production processes (i.e. Delta V).

+ Familiarity with deviation management systems (i.e. Phenix).

**FINE PRINT:**

+ This position may be required to be moved or temporarily flexed to another department or building within the Biologics operation due to business needs. Additionally, candidates should expect to work in multiple buildings. Some over-time/off shift work hours may be required based on business needs. We will attempt to provide as much advance notice as possible, two weeks where applicable if any such change is needed.

+ Must be able to lift up to 25 lbs, bend/lift/move objects as part of the job.

+ Able to stand for up to 8 hours a day (with occasional breaks)

**_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.

\#GD-SG

\#LI-GZ

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.

Keywords: Sanofi Group, Framingham , Manufacturing Associate - Night Shift, Other , Framingham, Massachusetts

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