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.
Robust 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).
Solid 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
Our Hiring Process
Screening (HR Round)
Technical Round 1
Technical Round 2
Final HR Round