MES Validation Engineer
Avispa
MES Validation Engineer
A leading biotechnology company is seeking a MES Validation Engineer to support the multi-phase deployment of Manufacturing Execution Systems (MES) within its Innovative Therapies organization. This role will focus on Computerized System Validation (CSV) activities in a GMP-regulated environment, supporting cutting-edge therapies including DNA/RNA, cell, and stem cell therapies. The ideal candidate will bring strong MES validation experience, expertise with Rockwell FactoryTalk PharmaSuite, and a solid understanding of regulatory requirements governing computerized systems.
MES Validation Engineer Responsibilities:
- Develop, author, execute, and route validation deliverables, including test scripts, validation protocols, and summary reports for computerized systems, ensuring compliance with FDA, EMA, GxP, and applicable industry standards.
- Partner cross-functionally with IT/OT teams, system owners, Quality, and business process owners to align validation and testing strategies with existing validated GMP systems and project objectives.
- Provide subject matter expertise on validation approaches, overall testing strategies, risk assessments, and Computerized System Validation (CSV) best practices throughout MES deployment activities.
- Execute formal validation activities within GMP environments, including managing testing plans, coordinating testing execution, and ensuring complete and compliant documentation.
- Assess and mitigate risks associated with computerized systems while supporting validation activities across regulated platforms such as MES, ERP systems, LIMS, SCADA, ValGenesis, and related life sciences technologies.
MES Validation Engineer Qualifications:
- 5 years of experience as a Validation professional with demonstrated experience developing and executing validation protocols for computerized systems.
- Bachelor's degree in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Biology, Computer Science, Technology, or a related life sciences discipline.
- Experience with Rockwell FactoryTalk PharmaSuite.
- Knowledge of Computerized System Validation (CSV) principles and regulatory requirements, including FDA, EMA, GxP, and applicable industry standards.
- Experience developing testing strategies, managing testing plans, and executing validation activities in GMP-regulated environments.
- Strong understanding of risk assessment methodologies and compliance best practices for computerized systems.
- Experience with regulated life sciences platforms, including ERP systems, ValGenesis, LIMS, SCADA, or similar technologies.
- Experience with MES Pharma Suite Writing is preferred.
- Professional certifications such as Certified Quality Engineer (CQE) or Certified Software Validation Specialist (CSVS) are preferred.
Vacancy posted 4 hours ago
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