MES Validation Engineer - Hillsboro, OR

Required Skills:
The ideal candidate brings:
Experience in Rockwell FactoryTalk PharmaSuite
5 years of experience as a Validation Professional; Proven experience in developing and executing validation protocols for computer systems
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
Bachelor s degree or equivalent in Biomedical Engineering, Regulatory Affairs, Chemistry, Biochemistry, Technology, Biology, Computer Science or a related life sciences discipline
(Preferred) Professional certifications in validation or related fields (e.g., Certified Quality Engineer (CQE), Certified Software Validation Specialist (CSVS)).
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