0817 MES Engineer
$166,400–$179,275 year
On-site · Hillsboro, Oregon, United States
Hillsboro, Oregon, United StatesOn-siteFull Time$166,400–$179,275 yearMid LevelBachelors DegreeUnknown
Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Validation Engineer on the MES team responsible for developing, drafting and routing validation protocols and test scripts for computer systems in a GMP environment, collaborating with ITOT, system owners, and quality partners to align validation strategy with validated systems, executing formal validation, and applying expertise in Rockwell FactoryTalk PharmaSuite and regulatory standards to support multi-phase MES deployment for Hillsboro site.
Required Qualifications
- 5 years of experience as a Validation Professional
- Experience with Rockwell FactoryTalk PharmaSuite
- Strong knowledge of regulatory requirements (FDA, EMA, GxP) and industry standards related to system validation
- Experience in developing and executing validation protocols for computer systems
- Bachelor’s degree in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science or related life sciences discipline
- Experience with industry tools such as ERP systems, ValGenesis, LIMS, SCADA and other regulated life sciences platforms
- Solid understanding of Computerized System Validation (CSV)
- Strong verbal and written communication skills
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