BEPC Inc. - Business Excellence Professional Consulting · 21 hours ago
MES Validation Engineer -29258_G
Hillsboro, OR
Contract
Hybrid
Senior Level
$90/hr - $94.95/hr
5+ years expBEPC Inc is seeking a MES Validation Engineer to join their Hillsboro Innovative Therapies team, which focuses on developing breakthrough medical advancements. The role involves supporting the multi-phase deployment of Manufacturing Execution Systems (MES) and collaborating with cross-functional teams to ensure compliance with regulatory standards.
BiotechnologyConsulting
Responsibilities
Develop, draft, and route for approval test scripts, validation protocols, and associated reports for computer systems in compliance with regulatory and industry standards
Execute formal validation activities within a GMP-regulated environment
Provide input into overall validation strategy for MES deployment projects
Guide test strategy development and ensure alignment with existing validated GMP systems
Collaborate with IT/OT, system owners, Quality partners, and business process owners to ensure validation strategies align with regulatory and operational requirements
Assess and mitigate risks associated with computerized systems
Support testing plan development and execution
Qualification
Required
BA/BS in Biology or related field
Minimum 5 years of experience as a Validation Professional
Strong experience with Computerized System Validation (CSV)
Proven experience developing and executing validation protocols for computer systems
Experience developing, drafting, routing, and executing test scripts
Strong knowledge of regulatory requirements (FDA, EMA, GxP) and industry standards related to system validation
Experience working in a GMP-regulated pharmaceutical or life sciences environment (pharma experience preferred)
Hands-on experience with MES systems
Experience with paperless validation tools such as ValGenesis
Strong written and verbal communication skills
Bachelor's degree (or equivalent) in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Biology, Computer Science, Technology, or related life sciences discipline
Experience managing testing plans and execution in complex system deployments
Ability to Commute: Hillsboro, OR 97124
Preferred
Experience with Rockwell FactoryTalk PharmaSuite
Experience with regulated life sciences platforms such as ERP systems, LIMS, SCADA
Professional certifications such as Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS), or similar
SCADA, LIMS ERP systems: 5 years
Benefits
Medical
Dental
Vision
Life Insurance
Company
BEPC Inc. - Business Excellence Professional Consulting
BEPC Incorporated provides Technical Engineering and Information Technology Project Management services to Fortune 500 companies in the industries: Life Science, Engineering, Manufacturing, Information Technologies, Advanced Technologies, Automotive, and Construction.
201-500 employees
H1B Sponsorship
BEPC Inc. - Business Excellence Professional Consulting 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
2025 (1)
2023 (3)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
Oscar Casillas
President and CEO
Andrew Casillas
Human Resources Partner
Company data provided by crunchbase