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Process Engineer II (Engineering)

Location: Allston, Massachusetts
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The Automation Engineering (AE) Group is responsible for design, implementation, support, and maintenance of automated engineering solutions in support of site goals and objectives. In such, AE is responsible for maintaining a stable, Qualified, and highly available computing infrastructure and implementation and Validated computer systems. 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, AE supports current project operations and ensures compliance with regulatory, corporate and site requirements.

This position is responsible for leading and supporting systems management, system maintenance, troubleshooting, and future enhancements. The person will be responsible for maintaining and providing technical support for plant process control equipment, and ensuring execution of production plan across multiple shifts.

Additional Responsibilities include:
• Leadership:
o Providing leadership and direction to support teams while embodying the principles of the Sanofi Global Leadership Model
o Ensuring timely issue escalation to manufacturing senior management and cross-functional support teams
o Partnering with support teams i.e., Manufacturing, Quality, etc to ensure adherence to production schedules, while holding direct reports and teams responsible for compliance to all safety and quality regulations.
o Ensuring that a consistent technical approach for Process Equipment Engineering and Automation is used across Projects.

• Problem Solving:
o Provide technical solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel. Solutions are imaginative, thorough, practical, and consistent with organization objectives.
• Training /Deviations /Compliance:
o Complying with Sanofi requirements for training, maintaining training at or above 95% on time
o Utilizing quality systems to measure, analyze, and improve team performance
o Partnering with direct and indirect management chain to ensure the following:
o Ensuring Inspection Readiness of assigned areas
o Overseeing completion of investigations and deviations.
• Partnering with QA to ensure the following:
o Ensuring all deviations and CAPA’s are closed in a timely manner
o Providing over sight for deviations and department documentation changes.
o Ensuring that Process, Equipment and Automation documentation is compliant and inspection ready.
o Complying with requirements from Genzyme’s Safety Program including Health and Safety regulations and OSHA requirements
• Production:
o Responsible for ensuring Process Equipment and Automation are available to support Operations Schedule Adherence requirements.
o Overseeing departmental projects and ensuring that the appropriate controls, approvals, and validation requirements are implemented
• Continuous Improvement:
o Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner
o Identifying opportunities to improve manufacturing processes and practices
o Ensuring all manufacturing management tools/systems and documentation (SOPs, MBR's, OJTs) is accurate
o Partnering with Manufacturing to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process
o Partnering with Lean Organization to drive business process improvements through Kaizens, Kanban, 5S and VSM.
o Ensuring that internal customers and suppliers are aligned with the needs and services provided by the Manufacturing Engineering team.

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