Senior Validation Engineer

Job title: Validation Engineer

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.

The Computer Systems Validation (CSV) team within Engineering and Maintenance (E&M) department is responsible to support the design, implementation, validation, and maintenance of Technology solutions in support of site goals and objectives; specifically, this team focuses on manufacturing systems & solutions including MES, DCS, PLCs, Data Historian & other integrated manufacturing systems. E&M 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, Digital Operations Technology supports current project operations and ensures compliance with regulatory, corporate, and site requirements.

This senior level validation engineer position is responsible for leading multiple computerized system validation projects and supporting the validation lifecycle of existing and new computerized systems and digital technologies. The person will be responsible for providing technical guidance related to Sanofi computer system validation directives aligned to CGMP regulations such as Part 11, ANNEX 11, etc. This position will develop and maintain validation procedures, templates, project plans, develop/update computerized system lifecycle processes, and deliver large-scale computerized system validation projects. Additionally, this position will also develop & deploy risk-based validation processes.

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

Leadership:

• Providing project leadership and technical guidance to teams and CSV projects while embodying the principles of the Sanofi Global Leadership Model
• Ensuring timely issue escalation to senior management and cross-functional support teams
• Partnering with support teams i.e., Digital, Automation, Manufacturing, Quality, etc to ensure adherence to production schedules, while ensuring compliance to all safety and quality regulations for CSV projects.
• Building and maintaining a highly collaborative relationship with the Digital and Automation teams and, specifically, with the QA validation team, and ensuring that CSV projects meet Quality and Data Integrity standards and procedures
• Mentoring junior Quality and CSV team members to ensure that the team applies compliant, efficient solutions to projects
  
  

Computerized System Validation

• Provide solutions to a wide range of difficult problems through individual efforts as well as leveraging of outsourced personnel. Solutions are imaginative, thorough, practical, and consistent with organization objectives and applicable regulations.
• Ensure that a consistent computerized system validation approach is utilized for Digital IT/OT infrastructure, Computerized Process Equipment, Manufacturing Computerized Systems, and Lab Systems.
• Develop/update and execute validation plans and computerized system lifecycle program documents to deliver large-scale computerized system validation projects.
• Maintain computer system inventories, perform GxP criticality assessments, and Electronic Records Electronic Signature assessments.
• Apply a risk-based approach to computerized system validation
• Maintain a validated state of computerized systems.
• Support internal and external audits.
• Ensure computerized systems meet applicable Data Integrity standards.
  
  

Training /Deviations /Compliance

• Complying with Sanofi requirements for training.
• Leads validation meetings, providing updates of project activities and project statuses.
• Supporting Inspection Readiness of assigned areas.
• Driving completion of investigations and deviations.
• Ensuring all deviations and CAPA’s are closed in a timely manner.
• Ensuring that MES, Automation, ERP, and other digital technology documentation is compliant and inspection ready.
• Participating in inspections conducted by external regulators.
• Complying with requirements from Genzyme’s Safety Program including Health and Safety regulations and OSHA requirements
  
  

Continuous Improvement

• Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner.
• Partnering with Manufacturing, Digital, and Quality to troubleshoot and drive resolution of validation issues and proactively driving effort to improve validation processes.
• Partnering with Operational Excellence to drive validation process improvements through Kaizens, Kanban, 5S and VSM.
  
  

About You

BASIC QUALIFICATIONS:

• Bachelor’s degree in Engineering, Science, or related technological field w/ 8 years of relevant work experience
• 5 years of experience developing and executing CSV plans and protocols, and deploying large scale computerized system validation projects in a manufacturing environment
• Familiarity with automated manufacturing systems
• Experience with ensuring Data Integrity for cGMP computerized systems.
• Experience with interpreting cGMP regulations for computerized systems (including 21 CFR Part 11, Annex 11).
  
  

Preferred Qualifications

• Hands-on experience with validation of Manufacturing Solutions including MES (Koerber PAS-X preferred), DCS (Delta V preferred), PLC & Data historian systems.
• Experience with agency inspections and audits presenting and supporting the CSV program and computer systems
• Strong Computer System Validation knowledge
  
  

Special Working Conditions

• Occasional manufacturing operations support on an “on-call” 24/7 basis
• Requires working in an industrial GMP manufacturing environment including the use of PPE and gowning.
  
  

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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