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A Range of Possibilities

Engineering Compliance Specialist

date posted 09/24/2021
contract type Full time
job id R2606413
location Framingham, Massachusetts

The Framingham Engineering, Projects & 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:

  • Framingham Biologics - comprised of commercial Fabrazyme, Thyrogen and Global Cell Banking operations.

  • Framingham Facilities Operations - responsible for campus wide facilities and utilities operations per established Service Level Agreements; and

  • 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.

The Compliance Specialist uses knowledge of Compliance and GXP to manage investigation and improvement initiatives within Engineering. This position is responsible for performing a variety of tasks under general guidance and in accordance with current GMP’s. Responsibilities include:

  • Assisting Engineering Manager with:

    • Training

    • Change Controls (CCR’s)

    • CAPA’s

    • Document Change Requests (DCR’s)

    • Deviations

  • Practices safe work habits and adheres to Sanofi’s safety procedures and guidelines

  • Participates in cross functional teams to drive investigation close outs, determine root cause and implement appropriate corrective and preventative actions

  • Participates on cross functional Continuous Improvement teams with Manufacturing, Validation, Quality, Facilities, Metrology and Maintenance

  • Coordinates SME assessments for all CCR’s assigned to the Engineering team

  • Work under general supervision and direction

  • Works closely with Engineering Manager to oversee and coordinate critical activities

  • Performs routine documentation assessments to ensure alignment between SOP’s/Standards

  • Participates in cross functional projects and performs SME assessments for all CCR’s assigned to Engineering

  • Works with the Scheduling team to report schedule adherence

  • Effectively demonstrates understanding of GMPs and how it applies to specific responsibilities

  • Trains new employees in Engineering Lifecycle

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

BASIC QUALIFICATIONS:

  • Bachelor’s Degree in a scientific field and 4 years of related experience, Associate's Degree and 6 years of related experience or High School Diploma and 8 years of related experience in a Quality and /or other CGMP related field.

  • Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and / or cGMP environment.

  • Basic to Intermediate computer proficiency, strong verbal, and written communication skills. • Experience with quality systems and cGMP data review.

  • Knowledge of biologics manufacturing and Engineering.

Special Working Conditions:

  • Ability to gown and gain entry to manufacturing areas

Preferred Qualifications:

  • Bachelor’s Degree in Biology, Chemistry, Biochemistry or Chemical Engineering

  • Experience in cGXP manufacturing environment

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

  • Familiarity with Deviation Management Systems (i.e. Trackwise)

  • Experience in troubleshooting, investigating and root cause analysis in a GXP environment

Competencies/Skills:

Demonstrated skills in the following areas:

  • Problem solving

  • Basic technical report writing

  • Verbal communication

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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