Tailored Management · 12 hours ago
MES Validation Engineer
Hillsboro, OR
Contract
Onsite
Senior Level
$69.93/hr - $90.91/hr
5+ years expTailored Management is focused on translating advanced medical innovations into commercial manufacturing. The MES Validation Engineer will implement and validate automation solutions to improve manufacturing efficiency and ensure compliance in a GMP-regulated environment.
ConsultingHuman ResourcesInformation Technology
Responsibilities
Develop, author, and route test scripts, validation protocols, and validation reports for computerized systems in compliance with regulatory and industry standards
Execute and support Computerized System Validation (CSV) activities in GMP environments
Collaborate with IT/OT, system owners, quality teams, and business process owners to align validation approaches with existing GMP systems
Contribute to and review overall validation and testing strategies for project deployments
Provide guidance on test planning and execution to ensure consistency with validated systems
Support risk assessments and compliance activities related to computerized systems
Qualification
Required
Hands-on experience with MES platforms, preferably Rockwell FactoryTalk PharmaSuite
Minimum 5 years of experience in computer system validation / CSV
Proven experience developing, drafting, and routing validation protocols and test scripts
Strong knowledge of GMP and regulatory standards (FDA, EMA, GxP)
Solid understanding of Computerized System Validation (CSV) frameworks
Experience assessing and mitigating validation and compliance risks
Strong written and verbal communication skills
Bachelor's degree (or equivalent) in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science, or related life sciences field
Preferred
Experience with paperless validation tools such as ValGenesis
Experience managing test plans and validation execution
Familiarity with regulated platforms such as ERP systems, LIMS, SCADA, and other life sciences applications
Professional certifications such as CQE or CSVS
Benefits
Weekly pay
Medical
Dental
Vision
Company
Tailored Management
Tailored Management is a staffing and recruiting company that offers information technology staffing and recruitment services.
501-1000 employees
H1B Sponsorship
Tailored Management has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Jeff Anderson
Managing Partner & Client Relations Executive
Savannah Deskins
Manager, Administration & Office of the CEO
Company data provided by crunchbase