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 5+ years' experience in the pharmaceutical or related industry.

  • OR Master’s degree in engineering or related scientific discipline, with 2+ years' experience in the pharmaceutical or related industry.

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

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

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 Know