Genentech USA · 8 hours ago
Validation Engineer
Hillsboro, OR
Contract
Onsite
Senior Level
$65/hr - $90/hr
5+ years expGenentech USA is a leading biotechnology company, and they are seeking a Validation Engineer to join their Manufacturing Execution System (MES) team. The role involves developing and executing validation protocols for computer systems, ensuring compliance with regulatory standards, and collaborating with various departments to optimize healthcare delivery for patients.
Information Technology & Services
Hiring Manager
Alister Grove
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
Benefits
Company
Genentech USA
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase