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Process Engineer

Framingham, Massachusetts



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Position Overview:

We are currently seeking a motivated candidate for the position of Engineer to join Sanofi’s Clinical Injectables Manufacturing organization, part of Research & Development, to perform early stage fill/finish manufacturing process development in a pilot facility in a regulated cGMP environment. The primary function of this role is to participate in startup activities for a new fill/finish facility.   Once online, the candidate will be the point person for maintaining continual operation, including maintenance and requalification activities. This will include coordination of initial and periodic PMs and calibrations and maintenance shutdowns for facilities, utilities and equipment.  The candidate should have the ability to operate complex systems and equipment in accordance with current GMPs and safety guidelines under limited supervision. 

Key Responsibilities:

  • Participate in the start-up activities for a new fill/finish facility including autoclave, parts washer, inspection system, lyophilizer and automated filling line under isolator.

  • Maintain continual operations, including maintenance and requalification activities.

  • Coordinate initial and periodic Preventative Maintenance (PMs) and calibrations and maintenance shutdowns for facilities, utilities and equipment.

  • Identification and proper application of all applicable Sanofi standards.

  • Lead a small group of technicians on a project basis.

  • Lead troubleshooting activities for a variety of process equipment and operations.

Basic Qualifications:

  • Bachelor’s degree in an engineering discipline with a minimum of 4 years of relevant experience within the Biotechnology or Pharmaceutical industry.

  • Ability to use technical, process, operational and regulatory understanding to develop strategies or solve problems.

  • Ability to operate complex systems and equipment in accordance with current GMPs and safety guidelines.

  • Excellent communication, time management and organizational skills.

  • Knowledge of GMP and how it applies to specific responsibilities and manufacturing operations.

  • Ability to interface with external and internal groups (QA, QC, Validation, Engineering and Vendors).

  • General knowledge of other related disciplines such as Automation, Instrumentation & Controls, Electrical.

  • SOP and Qualification writing and execution experience.

Preferred Qualifications:

  • Previous experience with fully automated filling equipment.

  • Previous experience in a cGMP manufacturing environment.

  • Experience with Digitalization.

  • Experience with product tech transfer.

Special Working Conditions

  • Push/pull/lift up to 50 pounds to move loaded, wheeled carts with assistance from another worker.

  • Frequent sitting, walking, standing, bending and squatting.

  • May require standing and walking up to 70% of day.

  • May involve work with hazardous materials.

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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