Job Details

Validation Engineer - Manufacturing Execution Systems (MES) - 100% Remote

Summary

The Hillsboro Innovative Therapies (HIT) team is at the forefront of bringing new medical advancements from development to commercial manufacturing. This role supports the deployment and validation of Manufacturing Execution Systems (MES) used in advanced therapies, including individualized DNA/RNA therapies, cell therapies, and stem cell therapies. The Validation Engineer will play a critical role in ensuring compliance, system reliability, and operational readiness within a GMP-regulated environment.

Responsibilities

• Develop, draft, review, and route validation protocols, test scripts, and associated reports for computerized systems.
• Ensure validation activities comply with applicable regulatory requirements and industry standards.
• Collaborate with IT/OT teams, system owners, quality partners, and business process owners to align validation strategies with existing GMP systems.
• Provide input and guidance on project validation strategies and overall testing approaches.
• Execute formal validation activities within a GMP-regulated environment.
• Assess risks associated with computerized systems and recommend mitigation strategies.
• Support multi-phase MES deployment initiatives and ensure compliance throughout implementation.
• Manage testing plans, testing execution, issue tracking, and validation documentation.
• Maintain accurate records and ensure validation deliverables meet quality and regulatory expectations.
• Support continuous improvement initiatives related to computerized system validation and MES processes.

• Bachelor's degree in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Computer Science, Biology, Technology, or a related life sciences discipline.
• Minimum 5 years of experience as a Validation Professional.
• Proven experience developing and executing validation protocols for computerized systems.
• Strong knowledge of FDA, EMA, GxP, and industry standards related to system validation.
• Solid understanding of Computerized System Validation (CSV).
• Experience with Rockwell FactoryTalk PharmaSuite.
• Strong risk assessment, analytical, problem-solving, and compliance management skills.
• Excellent verbal and written communication skills.

• Professional certifications such as Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS), or equivalent.
• Experience managing testing plans and validation execution activities.
• Experience with regulated life sciences systems and platforms including ERP systems, ValGenesis, LIMS, SCADA, and Manufacturing Execution Systems (MES).
• Knowledge of pharmaceutical, biotechnology, or advanced therapy manufacturing environments.

• Manufacturing Execution Systems (MES)
• Rockwell FactoryTalk PharmaSuite
• Computerized System Validation (CSV)
• GMP / GxP Compliance
• Validation Protocol Development
• Risk Assessment & Mitigation
• Testing Strategy & Execution
• FDA & EMA Regulatory Compliance
• Quality Systems
• ValGenesis, LIMS, ERP & SCADA Systems
• Cross-Functional Collaboration
• Technical Documentation