BEPC Inc. - Business Excellence Professional ConsultingHillsboro, OR 97124
$90.95 – $94.95 per hour
W2 Contract, 4-month contract with possible extensions
Role OverviewBEPC is seeking an experienced MES Validation Engineer to support Manufacturing Execution System (MES) deployment at an innovative therapies manufacturing site in Hillsboro, OR.
This role will focus on Computerized System Validation (CSV) activities within a GMP-regulated pharmaceutical manufacturing environment. The ideal candidate will have hands-on experience with MES systems, paperless validation tools (ValGenesis preferred), and developing and executing validation test scripts in compliance with FDA and global regulatory standards.
You will collaborate cross-functionally with IT/OT, Quality, system owners, and business stakeholders to ensure validated, compliant, and high-performing automation systems.
Develop, draft, route, and execute validation protocols, test scripts, and summary reports for computerized systems
Provide input into validation and overall test strategy for MES deployment
Ensure validation activities align with existing validated GMP systems
Collaborate with IT/OT, Quality, and business process owners to maintain compliance
Execute formal validation activities in a GMP environment
Assess and mitigate risks associated with computerized systems
Ensure compliance with FDA, EMA, GxP, and industry validation standards
Support paperless validation workflows (ValGenesis or similar platforms)
Manage testing plans and validation execution timelines
Bachelor's degree in Biomedical Engineering, Computer Science, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, or related life sciences discipline
5+ years of experience as a Validation Professional in a regulated environment
Strong Computerized System Validation (CSV) experience
Hands-on MES experience (Rockwell FactoryTalk PharmaSuite preferred)
Experience developing, drafting, and routing validation test scripts
Experience executing validation in GMP pharmaceutical environments
Knowledge of FDA, EMA, and GxP regulations
Strong written and verbal communication skills
Experience with paperless validation systems such as ValGenesis
Experience with ERP systems, LIMS, SCADA, and other regulated life sciences platforms
Professional certifications such as CQE or CSVS
Experience managing validation test plans and execution
Strong understanding of validation strategy and regulatory compliance
Ability to work independently while collaborating cross-functionally
Experience in pharma manufacturing environments (highly preferred)
Detail-oriented professional with strong documentation skills
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