Sanofi Group Validation Engineer III in Framingham, Massachusetts

Department Description:

The Framingham Engineering, and Project Controls organization is responsible for providing Engineering support to organizations on the Framingham campus. This organization is comprised of 3 groups: Engineering, Commissioning and Qualification and Projects and Controls.

The Framingham Engineering, Projects & Controls organization will be supporting the following groups at the Framingham campus: (1) Framingham Biologics - comprised of commercial Fabrazyme, Thyrogen and Global Cell Banking operations. (2) Framingham Facilities Operations - responsible for campus wide facilities and utilities operations per established Service Level Agreements and (3) Framingham Campus - in the context of programs/projects requiring approval, planning and execution across the Sanofi groups on the Framingham campus. While each business has its own Engineering support group, the Framingham Engineering, Projects and Controls organization will interact with all of these groups on projects/programs with campus impact.

This organization is responsible for providing Engineering support for all cGMP process and utility systems at Framingham Biologics, maintaining these systems in a validated state of control and ensuring uninterrupted business continuity. This organization is also responsible for shared GMP systems on the Framingham campus as defined by Service Level Agreements. The Capital Projects group is responsible for the planning and execution of projects and programs under its scope as determined by budget and other pre-established criteria, ensuring projects/programs are completed to established schedules and budget. The Commissioning and Qualification groups will be responsible for providing C&Q support to systems and projects/programs within the scope of this organization.

Summary Statement:

Responsible for validation activities related to one or more of the following areas: DQ, IQ, OQ, PQ, requalification, cleaning, sterilization, computer systems and/or PV activities.

Core Responsibilities:

• Perform validation in a GMP biotech manufacturing facility managing multiple medium to large size validation projects and providing technical assistance to less experienced technicians/engineers.

• Assist Manager/Associate Director in establishing and generating Validation department procedures.

• Develop Validation plans for medium to large size validation projects.

• Write, review and approve qualification/validation protocols and reports as well as execute protocols. Resolve protocol discrepancies and deviations.

• Knowledge of risk based validation approaches that meet current regulatory requirements, internal standards and industry practices.

• Responsible for peer review of validation reports and present the validation approach and study results to peers and managers.

• Present and defend validation studies during regulatory inspections and internal audits.

• Generate, review and approve deviations, CAPAs, perform/lead investigations and root cause analysis.

• Perform change control assessment.

• Perform SOP revision, review and approval.

• Complete all internal and external training.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

• Being honest and treating people with respect and courtesy.

• Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.

• Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• Bachelor’s degree in engineering/science or equivalent and 6+ years of validation or 10 years validation experience.

• Familiarity with applicable US and worldwide regulatory requirements.

• Ability to read/interpret engineering drawings and design documents.

• Management of small to medium size projects.

• Excellent technical writing and verbal communication skills.

• Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.

• Knowledge of Validation Lifecycle Approach.

Preferred Qualifications:

• Development of project execution plans for medium to large size projects.

• Understanding of Validation using risk based approach (FMEA).

• Demonstrated success working across organizations in highly matrixed/team environment.

• Proficient in use of GE/Kaye Validator as applicable.

Special Working Conditions:

• Requires some off-shift availability when necessary (typically 10-20% of the time) potentially including weekends and holidays.

• Ability to lift 20 lbs.

• Ability to gown.

• Ability to gain entry to confined space.

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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life