MindSource · 1 day ago
MES Validation Engineer
Hillsboro, OR
Full-time
Onsite
Senior Level
$65/hr - $90/hr
5+ years expMindSource is a company focused on optimizing healthcare through advanced automation technology. They are seeking a Validation Engineer to support the multi-phase deployment of Manufacturing Execution Systems (MES) and collaborate with various departments to enhance patient care.
SoftwareInformation TechnologyInformation Services
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
Benefits
Benefits
Company
MindSource
MindSource has delivered software solutions for over two decades to many hundreds of Silicon Valley companies.
201-500 employees
H1B Sponsorship
MindSource 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
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Gabriel Meza
CFO - VP of HR
Michael A. O'Rourke
Partner
Company data provided by crunchbase