Nesco Resource · 9 hours ago
Validation Engineer II
Hillsboro, OR
Full-time
Onsite
Mid, Senior Level
$70/hr - $75/hr
5+ years expNesco Resource is partnering with the Hillsboro Innovative Therapies team at Genentech, which focuses on advancing medical technologies. They are seeking a Validation Engineer II to support the deployment of Manufacturing Execution Systems (MES) and ensure compliance with regulatory standards through validation protocols and collaborative efforts with various departments.
ConsultingHuman ResourcesStaffing Agency
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 overall test strategy and ensure alignment with existing validated computer systems
Execute formal validation in a GMP environment
Qualification
Required
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
Benefits
MEC (Minimum Essential Coverage) plan that encompasses Medical
Vision
Dental
401K
EAP (Employee Assistance Program) services
Company
Nesco Resource
Nesco Resource s an Staffing and Recruiting firm.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Michael McDonald
Executive Vice President of Finance and Chief Accounting Officer
Recent News
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2023-12-24
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2023-12-24
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