Estuate, Inc. · 18 hours ago
MES Validation Engineer
Hillsboro, OR
Contract
Onsite
Senior Level
5+ years expEstuate, Inc. is seeking a MES Validation Engineer to ensure compliance with regulatory and industry standards through the development and execution of validation protocols. The role involves collaborating with various stakeholders to align validation strategies with existing systems and executing formal validation in a GMP environment.
Information Technology
Hiring Manager
Pradeep Mohan
Responsibilities
Develop, draft and route for approval overall test scripts, validation protocols and their associated reports for computer systems, ensuring they comply with relevant regulatory and industry standards
Work collaboratively with ITOT, system owner, quality partners and business process owner to ensure that strategies are aligned with existing GMP systems
Provide input on the validation strategy of the project
Provide guidance on overall test strategy and ensure alignment with existing validated computer systems
Execute formal validation in a GMP environment
Qualification
Required
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
Company
Estuate, Inc.
We at Estuate help you thrive with our out-of-the-box tech solutions.
201-500 employees
H1B Sponsorship
Estuate, Inc. 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 (17)
2024 (18)
2023 (8)
2022 (16)
2021 (12)
2020 (22)
Funding
Current Stage
Growth StageLeadership Team
P
Prakash Balebail
Founder and CEO
Nagaraja Kini
Co-Founder, CFO
Company data provided by crunchbase