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Associate Director Manufacturing Systems

Framingham, Massachusetts

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Overview

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    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

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Quote

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

ABOUT THE ROLE:

**Strong MES knowledge**

**Looking for individual from an automated manufacturing environment**

The Digital Operations Technology Group is responsible for design, implementation, validation, support, and maintenance of Technology solutions in support of site goals and objectives; specifically, this group focuses on manufacturing systems & solutions including MES, DCS, PLC, LIMS & related systems.  The Digital Operations Technology Group is responsible for maintaining a stable, qualified, validated, and highly available computing infrastructure; additionally, we are also responsible for ensuring data integrity for our computerized systems & processes.  This encompasses work processes that originate with the identification of a new or revised system, the design, installation, verification and validation of the system, the maintenance of the system in its commissioned/qualified/validated state and the retirement of the system at the end of its life. Additionally, through daily tasks, Digital Operations Technology supports current project operations and ensures compliance with regulatory, corporate and site requirements.

This position is responsible for managing MES & PI Engineering Staff and support systems management, maintenance, troubleshooting, and enhancements. This person will be responsible for maintaining and providing technical support for manufacturing systems across multiple shifts and managing staff performance against operational goals.

Additional Responsibilities Include:

Management:

  • Providing leadership and direction to support teams while embodying the principles of the Sanofi Global Leadership Model

  • Managing and developing the performance of direct reports by setting clear “SMART” goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance

  • Ensuring timely issue escalation to senior management and cross-functional support teams

  • Partnering with Manufacturing, Automation, F & E, Quality, Supply Chain, Finance, Global Digital, etc. to ensure adherence to production schedules, while holding direct reports and teams responsible for compliance to all safety and quality regulations.

  • Build and maintain a highly collaborative relationship with the Manufacturing, Automation, Supply Chain, CSV & Quality teams and, specifically, with the Production Heads, and ensure that MES & PI systems & processes are fully aligned with Quality standards and procedures

  • Working with recruiters to maintain staffing levels and meet approved hiring plans, conducting performance appraisals and career development assessments for all direct reports

  • Mentor team members to ensure that the team applies compliant, efficient solutions to projects

Manufacturing Systems management:

  • Provide solutions to a wide range of difficult problems through individual & team efforts as well as strategic leveraging of outsourced personnel.  Solutions are imaginative, thorough, practical, and consistent with organization objectives and applicable regulations

  • Manage the manufacturing systems function to ensure that systems are optimized and robust & timely support is provided to support manufacturing operations, processes, plans & schedules

  • Support internal and external audits

  • Ensure manufacturing systems meet applicable Data Integrity standards

Training /Deviations /Compliance:

  • Complying with Sanofi requirements for training

  • Utilizing quality systems to measure, analyze, and improve team performance

  • Leads staff meetings, providing updates of department activities and project statuses

  • Designing Department Training Plan and managing execution

  • Ensuring Inspection Readiness of assigned areas

  • Overseeing timely completion of manufacturing systems related investigations, CAPAs and deviations

  • Ensuring that manufacturing systems & documentation are compliant and inspection ready

  • Participating in inspections conducted by external regulators

  • Complying with requirements from Sanofi’s Safety Program including Health and Safety regulations and OSHA requirements

Continuous Improvement:

  • Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner

  • Partnering with Manufacturing and Quality to troubleshoot and drive resolution of manufacturing systems issues and proactively driving projects to improve manufacturing process

  • Partnering with Operational Excellence to drive process improvements through Kaizens, Kanban, 5S and VSM

BASIC QUALIFICATIONS:

  • Bachelor’s degree in Engineering, Science or related technological field or 10 years of relevant work experience, or

  • Master’s or PhD with 8 years of relevant work experience

  • Experience with Werum PAS X MES

  • Familiarity with PI

PREFERRED QUALIFICATIONS:

  • Manufacturing Automation experience would be a plus

  • Experience with cGMP environments would be a plus

SPECIAL WORKING CONDITIONS:

  • Occasional manufacturing operations support on an “on call” 24/7 basis

  • Requires working in an industrial manufacturing environment including gowning

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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