Job Title: MES Validation Engineer Location: Hillsboro, OR / Remote
Preferred experience: CSV validation MES Pharma suite Writing, executing & validating scripts Val Genesis Creating trace matrixes
Description:
The Hillsboro Innovative Therapies (HIT) team at Genentech 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.
Responsibilities
As a Validation Engineer, you will:
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
Who you are
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
Numbers & Facts
Location
Hillsboro, OR
Skills
Automationunmatched
Best Practicesunmatched
Biochemistryunmatched
Biologyunmatched
Biomedical Engineeringunmatched
Biotech and Pharmaceuticalunmatched
Business Processesunmatched
Certified Quality Engineer (CQE)unmatched
Chemistryunmatched
Communication Skillsunmatched
Computer Scienceunmatched
Computer Systemsunmatched
DNAunmatched
ERP (Enterprise Resource Planning)unmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Healthcareunmatched
Industry Standardsunmatched
Laboratory Information Management System (LIMS)unmatched
Leading Edge Technologyunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Execution Systems (MES)unmatched
People Managementunmatched
Presentation/Verbal Skillsunmatched
Regulationsunmatched
Risk Analysisunmatched
Risk Managementunmatched
Scripting (Scripting Languages)unmatched
Software Validationunmatched
Stem Cellsunmatched
Supervisory Control and Data Acquisition (SCADA)unmatched
System Validationunmatched
Test Plan/Scheduleunmatched
Test Scriptsunmatched
Test Strategyunmatched
Validation Planunmatched
Writing Skillsunmatched
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