Validation Engineer, CSV Biopharma (JP13826)
Company: 3 Key Consulting
Location: New Albany
Posted on: April 1, 2026
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Job Description:
Job Title: Validation Engineer, CSV Biopharma (JP13826)
Location: New Albany, OH. 43054 Business Unit: Ops Digital
Technology Innovation Employment Type: Contract Duration: 6 months
with likely extension Rate : $35-40/Hr on W2 with benefits Posting
Date: 3/18/2025 Target start date : 4/28/25 Notes: Onsite New
Albany, OH - must be local. Standard hours. 3 Key Consulting is
hiring! We are recruiting a CSV Validation Engineer for a
consulting engagement with our direct client, a leading global
biotechnology company. The ideal candidate: 3-5 years of experience
in computerized system validation, deviation management, CAPAs, and
change tickets within a GMP-regulated pharmaceutical,
biotechnology, or life sciences environment. They must hold a
Bachelor’s or master’s degree in computer science, Information
Technology, Management Information Systems, Mechanical Engineering,
or a related field, with a Master’s degree acceptable only if
accompanied by at least 3 years of industry experience (no fresh
graduates). The role requires onsite work with limited training
time, so candidates must be able to hit the ground running.
Overqualified candidates (e.g., PhDs or those with 15 years of
experience) may not be the best fit. Strong preference will be
given to candidates from a pharmaceutical, biotechnology, or life
sciences background. 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: No experience on Computer system validation/ validation
process. No experience on Deviations. Fresh graduates with no
validation or industry experience. Lack of experience with computer
system validation or deviation management. No background in Pharma,
Biotech, Life Sciences, or relevant IT/Validation roles. Candidates
switching from unrelated industries (since training time is
limited). Overqualified candidates with 15-20 years of experience
and/or candidates with PhDs. Interview Process: WebEx or onsite.
Interview rounds: Typically 2 rounds (with hiring manager and his
manager), but could extend to 3 rounds if needed We invite
qualified candidates to send your resume to
recruiting@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, Middletown , Validation Engineer, CSV Biopharma (JP13826), IT / Software / Systems , New Albany, Ohio
