Massachusetts Jobs

Senior Manufacturing Associate

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 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.

• Fulfills role of 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 less experienced operators.

• Fulfills the role of Team Lead in the absence of 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 meeting, +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.

ADDITIONAL RESPONSIBILITIES

• 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.

LEADERSHIP QUALIFICATIONS

• Capable of effective and clear communication that enables teams to execute on key deliverables

BASIC QUALIFICATIONS

• 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.

PREFERRED QUALIFICATIONS

• 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).

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.

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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.