Validation Specialist CSV & OT Systems

  • Muskegon, MI
  • Posted 12 hours ago | Updated 12 hours ago

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 12 Month(s)

Skills

Validation
CSV
GAMP
DeltaV
ABB DCS
OSI PI Historian
MES
21 CFR Part 11
Annex 11
cGMP
Gxp

Job Details

We are seeking a skilled Validation Specialist with hands-on experience in Computer System Validation (CSV) and Operational Technology (OT) systems. The successful candidate will support validation activities across control systems such as DeltaV, ABB DCS, Historian, MES, and other regulated automation platforms. You will work under the direction of the Validation Lead, Automation Lead, and Project Manager, performing validation tasks and ensuring compliance with GxP, FDA, and cGMP guidelines.

Key Responsibilities

  • Execute and document initial Computer System Validation (CSV) activities at the client site.

  • Conduct Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Site Acceptance Testing (SAT) for OT systems.

  • Review and approve risk assessments related to the validation of automation and control systems.

  • Collaborate with QA, IT, Automation, and Engineering teams to ensure seamless validation and compliance.

  • Ensure that all validation documentation meets internal standards and regulatory requirements.

  • Participate in Change Management processes and ensure controlled implementation of validated systems.

  • Maintain validation lifecycle documentation for systems such as DeltaV, ABB, MES, Historian, etc.

  • Identify and escalate compliance gaps or deviations in a timely manner.

Qualifications

  • Bachelor s degree in Engineering, Life Sciences, Computer Science, or related field.

  • Minimum 5 years of experience in validation and quality roles within regulated environments.

  • Strong experience with CSV and GAMP 5 methodologies.

  • Working knowledge of DeltaV, ABB DCS, OSI PI Historian, and MES systems.

  • Familiarity with regulatory standards including 21 CFR Part 11, Annex 11, cGMP, and GxP.

  • Excellent documentation and communication skills.

  • Experience in life sciences, pharmaceutical, or biotech industry is highly preferred.

Preferred Skills

  • Experience with automation systems integration and commissioning

  • Knowledge of data integrity and audit trail review

  • Experience with regulatory inspections or audits

  • Proficiency in validation tools and templates used in regulated environments

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