We are seeking a Computer Systems Validation (CSV) Engineer to support validation, delivery, and administration of GxP laboratory benchtop systems and enterprise systems. This role is part of the Digital Quality team and requires strong technical expertise along with hands-on validation experience.
The ideal candidate will be passionate about quality, continuous improvement, and optimizing systems to enhance user experience and business efficiency.
Key Responsibilities:
Collaborate with business analysts, IT teams, and automation engineers across the full product lifecycle of QC lab systems
Support benchtop systems such as HIAC, FTIR, TOC, Bioanalyzers, Sequencers, etc.
Work on enterprise systems like Chromatography Data Systems, Scientific Data Management Systems, and related platforms
Translate business and integration requirements into effective digital lab solutions
Drive system validation activities including implementation, upgrades, and incident resolution
Author and review validation lifecycle documentation (URS, FRS, Design Specs, SOPs, impact assessments, etc.)
Execute validation protocols in compliance with cGxP standards
Provide system administration and support for QC lab systems
Troubleshoot system issues and act as SME for root cause analysis and resolution
Perform periodic reviews, audit trail reviews, and user access reviews
Ensure GMP compliance and maintain inspection readiness
Support multiple projects in a fast-paced environment
Required Qualifications:
Bachelor’s degree in STEM or related field
Minimum 4+ years of experience in a cGxP regulated environment
Strong experience in Computer System Validation (CSV)
Experience authoring and reviewing validation lifecycle documents
Hands-on experience with QMS, Document Management systems, and ServiceNow
Experience working with validation tools such as KNEAT
Experience handling change controls, deviations, and CAPAs
Preferred Qualifications:
Experience with laboratory systems (TOC, Bioanalyzers, Spectramax/Softmax, etc.)
Experience with enterprise lab systems (Chromatography Data Systems, LabX, etc.)
Background in pharma, biotech, or life sciences industries
Experience with system integration and lab instrumentation connectivity
Familiarity with regulatory and compliance standards
Strong communication and collaboration skills
Ability to work independently and in cross-functional teams
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