Validation Engineer II, Framingham, MA
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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.
Position Overview and Responsibilities:
Responsible for validation activities related to one or more of the following areas: DQ, IQ, OQ, PQ, requalification, cleaning and/or sterilization activities.
Perform validation in a GMP biotech manufacturing facility managing medium sized validation projects and providing technical assistance to less experienced technicians/engineers.
Develop validation plans for small to medium sized validation projects and write qualification/validation protocols, execute protocols and author reports.
Resolve protocol discrepancies and deviations.
Knowledge of risk-based validation approaches that meet current regulatory requirements, internal standards and industry practices.
Responsible for the 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 deviations, CAPAs, perform investigations and root cause analysis.
Perform change control assessment.
Perform SOP revision, review and approval.
Complete all internal and external training.
Bachelor’s Degree with a minimum of 5-7 years of relevant experience OR
Master’s Degree with a minimum of 3-5 years of relevant experience OR
High School diploma with a minimum of 10 years of relevant experience
Development of project execution plans for medium to large sized 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.
Familiarity with applicable US and worldwide regulatory requirements.
Ability to read/interpret engineering drawings and design documents.
Management of small to medium sized projects.
Excellent technical writing and verbal communication skills.
Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
Knowledge of Validation Lifecycle Approach.
Special Working Conditions:
Requires some off-shift availability when necessary (typically 10-20% of the time), 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.
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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