Head of Engineering

Job Title: Head of Engineering

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi’s Mass BioCampus (MBC) Engineering organization is responsible for providing Engineering support to organizations on the MBC campus.  This organization is comprised of 3 groups:  Process Engineering, Plant Engineering and Electronic Document Management System (EDMS).

This organization is responsible for providing Process Engineering support for all cGMP process equipment at MBC Biologics, maintaining these systems in a validated state of control and ensuring uninterrupted business continuity.  This organization is also responsible for providing Project support on the MBC campus and work closely with MSAT to ensure continuity and compliance. 

Main Responsibilities:

This position is responsible for directing the Process engineering organization across the MBC Campus in support of commercial operations, new product introduction and product/process lifecycle management.

Management

• 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 manufacturing senior management and cross-functional support teams.

• Partnering with support teams i.e., Manufacturing, Quality, MSAT, etc. to ensure adherence to production schedules, while holding direct reports and teams responsible for compliance to all safety and quality regulations. Ensuring that appropriate levels of trained resources are available to meet production schedules.

• Accountable for staffing of site Engineering and Process Engineering teams based on site needs and strategic workforce planning.

Problem Solving

• Mentor Manufacturing Engineers to ensure that the team applies compliant, efficient engineering solutions to projects.

Training / Deviations / Compliance

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

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

• Partner with QA; Partner with direct and indirect management chain

• Participating in inspections conducted by external regulators

Production

• Responsible for ensuring Process Equipment are available to support Operations Schedule Adherence requirements.

Continuous Improvement

• Identifying opportunities to improve manufacturing processes and practices.

• Ensuring all manufacturing management tools/systems and documentation (SOPs, MBRs, OJTs) are accurate.

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

• Partnering with Lean Organization to drive business process improvements through Kaizens, Kanban, 5S and VSM.

Leadership Responsibilities:

• Leading People

• Leading the Business

• Delivering to Customers

About You

Minimum Requirements:

• Bachelor’s degree in engineering or related scientific discipline, with 12+ years' experience in the pharmaceutical or related industry.

  • OR Master’s degree in engineering or related scientific discipline, with 6+ years' experience in the pharmaceutical or related industry.

• Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements, including cGMP.

• 3+ years of proven leadership experience with a track record of managing and developing high-performing teams in a matrix environment

Preferred Qualifications

• Experienced in establishment of safe practices in a CGMP environment.

• Experienced working with cross-functional teams, including Quality, Manufacturing Technical Support, Facilities and Engineering, and Validation.

• Strong understanding of Good Engineering Practice, GMP and Quality Systems.

• Extended experience in Facility Design, Qualification and start-up for mammalian and microbial manufacturing facilities.

• Regulatory Knowledge:  Familiarity with pharmaceutical industry regulations, including FMP and FDA standards.

• Experienced with Deviation Management Systems (i.e. Trackwise).

• Experienced in investigation, root cause and risk analysis in a CGMP environment.

• Experienced leading the implementation of improvements to technical and business processes.

Special Working Conditions

·       Ability to gown and gain entry to manufacturing areas

Languages:

• Fluent English

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.​​

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.​​

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.​​

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.​

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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