Senior Validation Engineer
Company: Rang Technologies Inc.
Location: Indianapolis
Posted on: May 4, 2024
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Job Description:
*Job Description:-**Job Title: Senior Validation
Engineer**Location:* *1223 West Morris Street, Indianapolis, IN
46221**Contract: 9 Months with conversion possibility after 3
months**Monday to Friday 8am to 5pm**How will you make an
impact?*The Process Validation Engineer will mentor and support in
the diagnoses and resolution of software, instrument, and process
problems to maintain system readiness of both packaging equipment
and data historian network. You will ensure site compliance and all
vital activities are performed on time to keep all validated
systems in a validated state. In this role, you will also create
and implement the sites validation strategy.*What you will do**
Assess and define assigned validation projects. Liaise between
engineering and quality assurance throughout validation lifecycle
of packaging equipment and data historian network.* Develop
validation strategy based on URS and pFMEA.* Writing, reviewing,
and implementing project validation protocols for standard &
customized systems.* Raise discrepancies and closeout test
documentation.* Prepare validation summary reports for completed
protocols.* Conduct deviation investigations, such as validation
failures, complaints, and hold investigations. To Identify &
implement the appropriate corrective actions.* Applying structured
problem-solving tools, work with Operations to resolve technical
issues and rationalize impact to validated state.* Author
operational guidance documents (SOP/WI/JA/FORM) and conduct
trainings.* Travel to support FAT executions.* Partner with quality
assurance team to participate in internal and external audits to
defend equipment validation packages including calibration and
maintenance.*How you will get there:**Education:** Bachelor of
Science Degree in Engineering or another scientific subject area
from an accredited College or University*Experience:** Minimum of 3
years of validation experience in a regulated industry or
equivalent validation experience that included the development and
execution of FAT, SAT, and IQ/OQ protocols required.* Experience
with DeltaV or similar automation system preferred.* Experience
working with Trackwise, Maximo, and other electronic document
management systems preferred.* Experience applying Data Integrity
Principles (ALCOA) as part of standard work preferred.* Experience
with computer systems validation, cleaning validation, and
environmental monitoring preferred.* Demonstrated understanding of
cGMP, GDP, and regulatory requirements for automated systems, CPPs,
and CQAs, pFMEAs*Knowledge, Skills, Abilities:** Great teammate who
enjoys working on a dynamic team and making an impact* Driven to
successfully evaluate risks, opportunities, and roadblocks to make
the best decisions to achieve your goals and the teams goals.*
Diligent collaborator whose comfortable influencing, informing, and
instructing peers and members of the leadership team throughout all
levels of the organization.* Hands-on engineer with comfortability
being present in and working in and around manufacturing areas and
equipment.*We are an equal opportunity employer. It is our policy
to provide employment, compensation, and other benefits related to
employment without regard to race, color, religion, sex, gender,
national or ethnic origin, disability, veteran status, age, genetic
information, citizenship, or any other basis prohibited by
applicable federal, state, or local law.*Job Types: Full-time,
ContractPay: $40.00 per hourExpected hours: 40 per weekBenefits:*
Dental insurance* Health insurance* Paid time off* Vision
insuranceExperience level:* 4 yearsSchedule:* 8 hour shift* Monday
to FridayWork setting:* In-personAbility to Commute:* Indianapolis,
IN (Preferred)Ability to Relocate:* Indianapolis, IN: Relocate
before starting work (Preferred)Work Location: In personby
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Keywords: Rang Technologies Inc., Indianapolis , Senior Validation Engineer, Engineering , Indianapolis, Indiana
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