Engineer Senior, IT Business & Automation Systems Validation (JP13827)
Company: 3 Key Consulting
Location: New Albany
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer Senior, IT Business & Automation Systems
Validation (JP13827) Location: New Albany, OH. 43054 Business Unit:
Ops DTI Employment Type: Contract Duration: 1 year with likely
extensions and/or conversion to a permanent position. Rate: $50 -
$60/hour W2 DOE with Benefits Posting Date: 04/04/2025. Notes: Only
qualified candidates need apply. 3 Key Consulting is hiring! We are
recruiting an Engineer Senior, Business & Automation Systems
Validation for a consulting engagement with our direct client, a
leading global biotechnology company. Job Description: Primarily
responsible for ensuring adherence to computer validation standards
and procedures for computer-related systems. Responsibilities
include participation in system design, preparation of test
protocols, analysis of test results and preparation of summaries.
Provides guidance and sets standards in producing quality
documentation, serves as the liaison between the IS and Quality
functions, provides testing and IT compliance guidance, and
provides timely and effective response and follow-through in the
resolution of IT Quality/Project compliance issues. This role is
for a strong background in IT Business systems validation, IT
Automation systems validation, ensuring that our Information
technology systems and processes meet regulatory requirements and
industry standards, particularly within the framework of GxP (Good
manufacturing Practice) in projects. Integrates a variety of
systems technologies to provide systems related solutions to meet
business needs. Supports the creation and maintenance of our
client’s Ohio's computer systems validation. • Perform Deviations,
CAPA, Change records for Technology computer systems (E.g: MES,
SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc). •
Provide support to system owners on completion of Design
Specifications, URS, Traceability, IQ (Installation Qualification),
OQ (Operational Qualification), PQ (Performance Qualification)
draft copies. • Provide support to complete the validation
deliverables as required per the project. • Develop and execute
test scripts in ALM, Kneat test tools to support system owners/IT
Application Owners. • Ensure and track computer systems periodic
reviews and periodic access reviews are completed as per schedule
to maintain system maintenance phase. • Perform system periodic
reviews for Computerized systems, Automation systems. • Familiar
with validating SCADA, MES, PI Factory Talk Historian,
Serialization systems. • Ensures that systems are maintained in a
compliant manner according to the Technology quality systems
standards. • Support regulatory inspections and internal audits as
required. Top Must Have Skill Sets: • Experience with ALM or Kneat
testing tool is plus. • Experience with ServiceNow (Problem, Change
management), Track wise (Change Management), Veeva (Document
management, CAPA, Deviations, Change Management). • Knowledge of
cGMP regulations and guidelines including but not limited to U.S.
code of Federal Regulations 21 CFR Part 11 and Part 211. •
Understanding of industry standards and best practices for computer
system validation such as GAMP 5. • Perform Deviations, CAPA,
Change records for Technology computer systems (E.g: MES, SCADA,
ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc). Day to Day
Responsibilities: • Perform Deviations, CAPA, Change records for
Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow,
QBAS, SAP/ERP, Serialization, etc). • Provide support to system
owners on completion of Design Spec, URS, Traceability, IQ
(Installation Qualification), OQ (Operational Qualification), PQ
(Performance Qualification) draft copies. • Provide support on
completion of validation deliverables as required per the project.
• Develop and execute test scripts in ALM, Kneat test tools to
support system owners/IT Application Owners. • Ensure and track
computer systems periodic reviews and periodic access reviews are
completed as per schedule to maintain system maintenance phase. •
Ensures that systems are maintained in a compliant manner according
to the DTI quality systems standards. • Support regulatory
inspections and internal audits as required. Basic Qualifications:
• Bachelor’s or Master’s Degree in a science or Engineering
discipline required. • 7 years relevant experience in computer
system validation (E.g: MES, SCADA, PI Factory Talk Historian,
Building Management system (BMS, QBAS), Serialization, QC systems).
• Basic Qualifications Red Flags: • No experience on computer
validation process. • No background from life Sciences/Bio
Technology. • No experience on system deviations, CAPA, Change
management. • No knowledge on data integrity ALCOA, ALCOA
principles. Interview Process: Webex, or In-person We invite
qualified candidates to send your resume to
resumes@3keyconsulting.com. If you decide that you’re not
interested in pursuing this particular position, please feel free
to take a look at the other positions on our website
www.3keyconsulting.com/careers. You are also welcome to share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Hamilton , Engineer Senior, IT Business & Automation Systems Validation (JP13827), IT / Software / Systems , New Albany, Ohio
