MES Validation Engineer

MES Validation Engineer

The Hillsboro Innovative Therapies (HIT) team at *** is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. We work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies. As a member of our Manufacturing Execution System (MES) team, you will have the opportunity to bring state of the art automation technology to our site, optimizing our ability to serve patients efficiently. You 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 overall test strategy and ensure alignment with existing validated computer systems Execute formal validation in a GMP environment

The ideal candidate brings: Experience in Rockwell FactoryTalk PharmaSuite 5 years of experience as a Validation Professional; Proven experience in developing and executing validation protocols for computer systems 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 Bachelor's degree or equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science or a related life sciences discipline (Preferred) Professional certifications in validation or related fields (e.g., Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS)). 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.