Head of Automation and Manufacturing Systems

Job title : Head of Automation and Manufacturing Systems

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.

As Head of Automation and Manufacturing Systems within our Digital Engineering group, you will

• serve as the leader of the Manufacturing Systems & Automation (MS&A) Group, a multi-discipline group that develops, plans, implements, and supports MBC MS&A Strategy Roadmap.

• be responsible for the overall OT strategy and execution for the Massachusetts BioCampus (MBC).

• create and maintain the strategy and priorities across all manufacturing and automation systems on the site. In this vital role they will lead the MBC, incorporating the latest digital advancements in alignment with Industry 4. 0/Smart Manufacturing principals.

The Manufacturing Systems & Automation (MS&A) 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 & related systems. MS&A 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, MS&A supports current project operations and ensures compliance with regulatory, corporate and site requirements.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Develop & implement site manufacturing systems & automation strategy aligning goals.

• Ensure compliance & CSV for OT and Automation Systems

• Manage and optimize automation systems' performance.

• Lead MES support, ensure operational efficiency.

• Implement cyber security measures for OT systems.

• Apply Standards, manage obsolescence, drive innovation.

• Create collaborative relationships with corporate to harmonize practices and support

• Hire, mentor, develop lead and deploy hardworking digital/automation professionals who will work closely with personnel to create innovative and effective solutions for Site functional areas.

• Relentlessly focus on talent development of the next generations of biopharma professionals including mentoring process automation, Manufacturing Execution System engineers and data analysts

• Interface with the Information Technology Systems function to ensure appropriate system architecture, deployment of core IT systems and adherence and implementation of the cybersecurity strategy

Is Involved in the Following Key Decisions as Decision Maker (D), Advisor (A), Informed (I):

• D/A: Decide automation strategy and system sections

• A: Advise upgrades and ensure regulatory compliance

• D/A: Manage cyberscecurity, ensure data integrity measures

• D: Develop SOPs, lead staff training programs

• A: Guide budget allocation and vendor management

• D/A: Drive standards adoption, define performance metrics

Leadership Qualifications

• Leading People - Sanofi's leaders motivate, inspire, build, and retain highly effective teams. They are versatile learners and courageous decision makers.

• Leading the Business - Sanofi's leaders are effective operating in an evolving, complex, and dynamic environment, providing clear direction and instruction to supervisors and direct reports, and continuously looking internally and externally for best practices and areas for improvement.

• Delivering to Customers - Sanofi's leaders understand patient and customer needs and build relationships. They create a vision for the organization while continuously improving operations by holding teams accountable to the highest standards of performance.

About You

Basic Qualifications

• Master's degree in Engineering, Science, or related technological field with 12+ years Digital/Automation or Information System experience OR Bachelor's degree in Engineering, Science, or related technological field with 15+ years of relevant work experience AND 7+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

• Experience with several of the following systems: OSI PI, Rockwell, MES, Honeywell, Siemens and Emerson DeltaV systems

• 10+ years of automation and/or information system experience

• Expertise in Data Integrity and experience dealing with regulatory agencies

• Biopharma and/or Pharmaceutical experience

• Technical depths across Information and Operations Technology (IT/OT)

• Strong Knowledge of GMP, GAMP & 21CFR11

• Experience resolving issues, designing strategies, and implementing solutions as they pertain to global, multi system environments

• Experience at developing system migration and evolution strategies and turning the strategies into plans which are implemented

• Adaptability, teamwork, and decisiveness in rapidly changing/growing business environments

• Operational experience with GxP & IT change management across domains (security, software, network, hardware, etc)

• Prior experience in managing digital shop floor operations in a regulated environment(s).

• Accountability/Responsibility of 24/7/365 mission critical services and supporting Manufacturing, Engineering, QC Labs, and Quality

Preferred Qualifications

• Data analytics and continuous improvement methodologies

• Experience with industry 4. 0 technologies implementation

• Direct working experience with enterprise systems (e. g. , SAP, Workday)

Special Working Conditions

• Occasional ability to provide off-hours support

• Requires working in an industrial manu.