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Validation Specialist I-Framingham,MA


This is a Contract position in Framingham, MA posted June 12, 2019.

Validation Specialist I-Framingham,MADepartment Description:The Framingham Engineering, and Project Controls organization is responsible for providingEngineering support to organizations on the Framingham campus.

This organization iscomprised of 3 groups: Engineering, Commissioning and Qualification and Projects andControls.The Framingham Engineering, Projects & Controls organization will be supporting thefollowing groups at the Framingham campus: (1) Framingham Biologics
– comprised ofcommercial Fabrazyme, Thyrogen and Global Cell Banking operations.

(2) FraminghamFacilities Operations
– responsible for campus wide facilities and utilities operations perestablished Service Level Agreements and (3) Framingham Campus
– in the context ofprograms/projects requiring approval, planning and execution across the Sanofi groups on theFramingham campus.

While each business has its own Engineering support group, theFramingham Engineering, Projects and Controls organization will interact with all of thesegroups on projects/programs with campus impact.This organization is responsible for providing Engineering support for all cGMP process andutility systems at Framingham Biologics, maintaining these systems in a validated state ofcontrol and ensuring uninterrupted business continuity.

This organization is also responsiblefor shared GMP systems on the Framingham campus as defined by Service LevelAgreements.

The Capital Projects group is responsible for the planning and execution ofprojects and programs under its scope as determined by budget and other pre-establishedcriteria, ensuring projects/programs are completed to established schedules and budget.

TheCommissioning and Qualification groups will be responsible for providing C&Q support tosystems and projects/programs within the scope of this organization.Summary StatementResponsible 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 activities in a GMP biotech manufacturing facility.
• May manage small size validation projects and change control basedqualification/validation activities.
• Develop Validation plans for small change control based validation projects.
• Write qualification/validation protocols, execute protocols and author reports.

Resolveprotocol discrepancies and deviations.
• Knowledge of internal standards and industry practices.
• Present validation approach and study results to peers and managers.
• Present and defend validation studies during regulatory inspections and internalaudits.
• 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.Leadership Qualifications:An ongoing commitment to conducting our global business according to the highest legal andethical standards, and to continually pursue excellence in the development and delivery of allof our products and services.

This includes:
• Adhering to all applicable laws and regulations of the places in which we conductbusiness, 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 respectedfor the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly andhonestly in our dealings and exercising sound judgment in performing our jobs.Basic Qualifications:
• Bachelor’s degree in engineering/science or equivalent and 2 years of validation or 6years validation experience.
• Familiarity with applicable US and worldwide regulatory requirements.
• Ability to read/interpret engineering drawings and design documents.
• Management of small 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).
• Experience of 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.GD-SGLI-GZ 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.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