Validation Engineer, CSV Biopharma (JP12934-R)
Company: 3 Key Consulting
Location: New Albany
Posted on: April 1, 2026
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Job Description:
Job Title: Validation Engineer, CSV Biopharma (JP12934-R)
Location: New Albany, OH. 43054 Business Unit: Ops Digital
Technology Innovation Employment Type: Contract Duration: 6 months
with likely extension Rate : $35-40/Hr with benefits Posting Date:
3/18/2025 Notes: Onsite New Albany, OH - must be local. Standard
hours. 3 Key Consulting is hiring! We are recruiting a Validation
Engineer 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 client’s
Ohio computer systems validation. Top Must Have Skill Sets:
Experience with testing tools (ALM, or Kneat or ValGenesis).
Experience with ServiceNow (Change Module), Track wise (CAPA,
Deviations, Change), 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. Must
have experience with deviations IT infrastructure tools is highly
preferred but not required (example: backup and restore, disaster
recovery) Day to Day Responsibilities: Perform Deviations, CAPA,
Change records for DTI computer systems (E.g: MES, SCADA, ASRS,
ServiceNow, QBAS, SAP/ERP, Serialization, etc). Provide support to
system owners on completing 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:
Master degree OR Bachelor degree in Engineering and 2 years of
experience OR Associate degree and 6 years of experience OR High
school diploma / GED and 8 years of experience 2. 5 years relevant
experience in computer system validation (E.g: MES, SCADA, Building
Management system (BMS, QBAS), Serialization, QC systems).
Experience with ALM or Kneat testing tool is plus. 2. Experience
with ServiceNow, Track wise (CAPA, Deviations), Veeva document
management, CAPA, Deviations, Change Management. 3. Knowledge of
cGMP regulations and guidelines including but not limited to U.S.
code of Federal Regulations 21 CFR Part 11 and Part 211. 4.
Understanding of industry standards and best practices for computer
system validation such as GAMP 5. Why is the Position Open?
Supplement additional workload on team. Red Flags: cannot support
onsite operations Overly long or irrelevant resume Exaggerated or
vague job titles and responsibilities Lack of achievements or
quantifiable results Interview Process: WebEx or onsite. 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, Elyria , Validation Engineer, CSV Biopharma (JP12934-R), IT / Software / Systems , New Albany, Ohio
