MES Validation Engineer

MES Validation Engineer

• Hourly pay: $80-$90/hr
• Worksite:
  Leading biotechnology company (Hillsboro, OR 97124 – Onsite, Open to remote candidates in the United States)
• W2 Employment,
  Group Medical, Dental, Vision, Life, Retirement Savings Program
• 40 hours/week, 4 Month Assignment, Possible extension

A leading biotechnology company is seeking a MES Validation Engineer
. The successful candidate will play a crucial role in supporting the multi-phase deployment of MES. As a Validation Engineer, you will own a dynamic range of responsibilities where you will have the chance to work collaboratively with various departments and contribute to the advancement of healthcare for patients in need.

• Develop, draft, and route for approval overall test scripts, validation protocols, and their associated reports for computer systems, ensuring they comply with relevant regulatory and industry standards.
• Work collaboratively with ITOT, system owner, quality partners and business process owner to ensure that strategies are aligned with existing GMP systems.
• Provide input on the validation strategy of the project.
• Provide guidance on the overall test strategy and ensure alignment with existing validated computer systems.
• Execute formal validation in a GMP environment.

• 5 years of experience as a Validation Professional;
  Proven experience in developing and executing validation protocols for computer systems.
• Bachelor’s degree or equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science, or a related life sciences discipline.
• Experience in Rockwell Factory Talk Pharma Suite.
• Experience in managing testing plans and testing execution.
• Experience with industry‑specific tools such as ERP systems, Val Genesis, LIMS, SCADA, and other regulated life sciences platforms.
• Strong knowledge of regulatory requirements such as FDA, EMA, GxP, and industry standards related to system validation.
• Ability to assess and mitigate risks associated with computer systems and ensure compliance with industry best practices.
• A solid understanding of Computerized System Validation (CSV).
• Strong verbal and written communication skills.
• Professional certifications in validation or related fields (e.g., Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS) is preferred).
• GMP (pharma ideal), MES system experience, Test scripts (Develop, draft, and routing).