Sanofi Group Automation Engineer III ( Biotech Mfg) in Allston, Massachusetts

The Information Technology (IT) Group is responsible for design, implementation, support, and maintenance of Information Technology solutions in support of site goals and objectives. In such, IT is responsible for maintaining a stable, Qualified, and highly available computing infrastructure and implementation and Validated computer systems. Additionally, through daily tasks, IT supports current project operations and ensures compliance with regulatory, corporate and site requirements.

Summary:

Primary system administrator and technical system owner for automated Building Management System (BMS).

KEY RESPONSIBILITIES

  • Act as system administrator for the BMS system and act as subject matter expert regarding technical issues

  • Provide leadership and “hands on” support, as needed, to identify, contain, correct and close all quality system deficiencies related to the BMS and other shop floor applications

  • Develop and implement project(s) as appropriate to maintain the BMS and other manufacturing floor applications system throughout the component and software lifecycle

  • Troubleshoot technical issues and configure applications and software components.

  • Develop and implement backup and recovery strategies and drive consistency on system maintenance between BMS systems and other shop floor applications

  • Develop and maintain IS lifecycle management approaches based on Sanofi standards.

  • Communicate and interact with BMS contractors to ensure that work is performed safely and in a qualified manner

  • Create, manage and maintain end user accounts and corresponding BMS documentation.

  • Provide technical expertise and leadership to define approaches and execution of system validation activities in accordance with cGxP, CFR 21 Parts 11, 210 and 211, Annex 11 and other applicable regulations or procedures

BASIC QUALIFICATIONS:

  • Bachelor’s degree in Engineering, Computer Science or related technological field and 7 years of relevant work experience, or

  • Master’s Degree in Engineering, Computer Science or related technological field and 5 years of relevant work experience.

  • Previous experience with automation systems.

  • Effective written and verbal communications skills.

PREFERRED QUALIFICATIONS:

  • Exposure to or direct experience with regulated environments (i.e. cGMP, OSHA, EPA).

  • Previous experience in a manufacturing or operations environment.

  • Experience with one of the following Genzyme platforms: DeltaV, Allen Bradley PLC, OSI Soft PI historian, Instrumentation and control panel hardware as required by the job.

  • Experience with computer systems validation practices (GAMP).

  • Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.

  • Experience in managing small to medium-sized projects and outside vendors.

SPECIAL WORKING CONDITIONS:

  • Required to be part of on-call rotation for off-hours manufacturing support.

  • Requires working in an industrial manufacturing environment including gowning.

DISCLAIMER:

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.#LI-GZ #GD-GZ

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.