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.
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