Avispa · 1 day ago
MES Validation Engineer
Hillsboro, OR
Full-time
Onsite
Senior Level
$80/hr - $95/hr
5+ years expAvispa Technology is a leading biotechnology company seeking a MES Validation Engineer. The successful candidate will support the multi-phase deployment of MES and will be responsible for developing validation protocols and ensuring compliance with regulatory standards.
Human ResourcesRecruitingStaffing 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 partner,s 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 onthe overall test strategy and ensure alignment with existing validated computer systems
Execute formal validation in a GMP environment
Qualification
Required
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
Preferred
Professional certifications in validation or related fields (e.g., Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS) is preferred
Benefits
Group Medical
Dental
Vision
Life
Retirement Savings Program
PSL
Company
Avispa
At Avispa, we ensure our contractors are as satisfied as the companies we place them with.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Rothman Moncayo
Founder & CEO
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