TalentBurst, an Inc 5000 company · 1 day ago
MES Validation Engineer
Hillsboro, OR
Contract
Onsite
Senior Level
5+ years expTalentBurst, an Inc 5000 company, is seeking a MES Validation Engineer to join their Hillsboro Innovative Therapies team. This role involves supporting the multi-phase deployment of Manufacturing Execution Systems (MES) and ensuring compliance with regulatory standards through the development and execution of validation protocols.
Human ResourcesRecruitingStaffing Agency
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
TalentBurst, an Inc 5000 company
Founded in 2002, TalentBurst is an MBE and JCC certified firm that provides award winning solutions globally.
1001-5000 employees
H1B Sponsorship
TalentBurst, an Inc 5000 company 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 (3)
2023 (7)
2021 (1)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Jamie Jacobs (she/her)
Sr Vice President of Strategic Partnerships and DE&I/ESG Council
Recent News
WBJournal.com
2026-02-07
2025-11-19
Seattle TechFlash
2025-04-17
Company data provided by crunchbase