MES Validation Engineer

Job Title: MES Validation Engineer

Duration: 4+ months (possible extension)

Location: Hillsboro Oregon 97124

We are seeking an experienced MES Validation Engineer to support the multi-phase deployment and validation of Manufacturing Execution Systems (MES) within a regulated manufacturing environment. This role will focus on ensuring computerized systems are validated in compliance with applicable regulatory requirements and industry standards. The ideal candidate will collaborate cross-functionally with IT, quality, automation, and business teams to develop and execute validation strategies that support efficient and compliant manufacturing operations.

• Develop, draft, review, and route validation documentation including test scripts, validation protocols, and final reports for computerized systems.
• Ensure all validation activities comply with applicable regulatory requirements and industry standards (e.g., GxP).
• Collaborate with IT/OT, system owners, quality assurance, and business process owners to align validation strategies with existing validated systems.
• Provide input into overall project validation strategy and risk assessments.
• Guide overall test strategy development and ensure integration with validated environments.
• Execute formal validation activities in a GMP-regulated environment.
• Identify, assess, and mitigate risks associated with computerized systems.
• Support continuous improvement of validation processes and documentation practices.

• Minimum 5 years of experience as a Validation Professional in a regulated environment.
• Proven experience developing and executing validation protocols for computerized systems.
• Strong knowledge of regulatory requirements such as FDA, EMA, GxP, and industry standards related to system validation.
• Solid understanding of Computerized System Validation (CSV) principles.
• Experience with Rockwell Factory Talk Pharma Suite.
• Experience managing testing plans and execution.
• Experience with industry tools such as ERP systems, Val Genesis, LIMS, SCADA, and other regulated life sciences platforms.
• Strong verbal and written communication skills.
• Bachelor’s degree (or equivalent experience) in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Biology, Computer Science, Technology, or related life sciences discipline.

• Professional certifications in validation or related disciplines (e.g., Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS)).