TSR Consulting · 1 week ago
Computer System Validation Engineer
Bothell, WA
Contract
Hybrid
Mid Level
$74/hr - $75/hr
4+ years expTSR Consulting is a premier National U.S. Staffing company, and they are seeking a Computer System Validation Engineer for a leading pharmaceutical client. The role involves leading validation activities for GxP electronic systems, ensuring compliance with regulations, and developing necessary documentation for Manufacturing Execution Systems (MES).
Recruiting
Responsibilities
Works cross-functionally to lead and execute validation activities for GxP electronic systems and applications
Primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with procedures and regulations
Author, review and/or approve applicable CSV documentation
Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices
Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing
Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow)
Knowledge and exposure to Business Quality Management Systems (i.e. Veeva)
Understanding of computer system validation
Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch)
Qualification
Required
Strong Computer Systems Validation (CSV) experience, Manufacturing Execution Systems (MES), Protocol drafting and execution
4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices
Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing
Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow)
Knowledge and exposure to Business Quality Management Systems (i.e. Veeva)
Understanding of computer system validation
Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch)
Company
TSR Consulting
TSR is a relationship-based, customer-focused IT and technical services staffing company.
501-1000 employees
H1B Sponsorship
TSR Consulting 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 (4)
2024 (1)
2023 (3)
2022 (6)
2021 (1)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
unknown2012-08-20IPO
Leadership Team
Thomas Salerno
CEO
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