MES Validation Engineer

MES Validation Engineer ROCGJP00039534

• 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.

MES Validation Engineer Responsibilities:

• 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.

MES Validation Engineer Qualifications:

• 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 FactoryTalk PharmaSuite.
• Experience in managing testing plans and testing execution.
• Experience with industry-specific tools such as ERP systems, ValGenesis, 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).

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