Job Details

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 ...@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