Validation & CSV Consultant

Job Descritpion of Validation & CSV Consultant

10+ Years Relevant Experience

We are seeking a highly experienced MES Validation Engineer to support the validation and implementation of MES tools such as Rockwell FTPS, Honeywell MES, and related systems within regulated environments.

Key Responsibilities:

• Develop and execute validation protocols (IQ/OQ/PQ) for Rockwell FTPS, Honeywell MES, or similar MES platforms.
• Ensure compliance with FDA, GMP, GAMP, and other relevant industry regulations.
• Collaborate with IT, Quality, and Manufacturing teams to ensure successful validation outcomes.
• Conduct risk assessments and implement mitigation strategies for validation processes.
• Maintain accurate validation documentation and audit-ready records.
• Troubleshoot issues during validation and post-implementation phases.
• Provide user training and support for validated MES/LIMS systems.
• Lead or support system validation strategies including interface validation with LIMS and SAP.
• Manage legacy data migration and qualification activities.
• Utilize Kneat for validation testing and documentation (preferred).
• Participate in continuous improvement efforts to optimize validation methodologies.

Qualifications:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
• 5–10 years of hands-on validation experience in pharma, biotech, or manufacturing sectors.
• Strong expertise in Rockwell FTPS, PharmaSuite, and/or Honeywell MES.
• Working knowledge of OT validation, data migration, and system integrations.
• Familiarity with regulatory compliance including FDA 21 CFR Part 11, Annex 11, and GAMP 5.
• Proficiency in Microsoft Office Suite and validation tools (preferably Kneat).
• Strong analytical, communication, and cross-functional collaboration skills.

Preferred Skills:

• Experience with MES-LIMS and MES-SAP interface validation.
• Experience using Kneat Validation Software.
• Background in OT system validation and commissioning.

Required Skills for Validation & CSV Consultant Job

PHARMASUITE

Rockwell

Honeywell MES

OT Validation

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