Validation Engineer II, Framingham, MA
Company: Sanofi
Location: Framingham
Posted on: May 8, 2022
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Job Description:
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) FraminghamFacilities 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:Summary StatementResponsible for
validation activities related to one or more of the following
areas: DQ, IQ, OQ, PQ, requalification, cleaning and/or
sterilization activities.Core Responsibilities: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.Basic Qualifications:Bachelor's Degree with a
minimum of 5-7 years of relevant experience ORMaster's Degree with
a minimum of 3-5 years of relevant experience ORHigh School diploma
with a minimum of 10 years of relevant experiencePreferred
Qualifications: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.As a
healthcare company and a vaccine manufacturer, Sanofi has an
important responsibility to protect individual and public health.
This position will require individuals to be fully vaccinated
against COVID-19 as part of your job responsibilities.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-GZPDNAt 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.PDN-94c0a85e-6c5a-4210-823d-e851fb9a0973
Keywords: Sanofi, Framingham , Validation Engineer II, Framingham, MA, Engineering , Framingham, Massachusetts
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