[Hiring] MES Validation Engineer @Avispa Technology

Role Description

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.

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.

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.

Requirements

• Hourly pay: $70-$80/hr
• Worksite: Leading biotechnology company (Hillsboro, OR 97124 - Remote)
• W2 Employment
• Group Medical, Dental, Vision, Life
• Retirement Savings Program
• PSL
• 40 hours/week, 6 Month Assignment