Katalyst CRO
Posted 23 days agoVerified live 2d ago
Computer System Validation Engineer
Brief overview
Remote
UndergradOr in progress
3+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Computer System ValidationcGMP requirementsData Integrity principles (ALCOA)Risk assessmentChange managementBackup policiesConfiguration managementValidation documentationUser acceptance testingSystem impact assessmentTraceability matricesProtocol developmentPharmaceutical regulatory complianceUS data integrity guidanceEU/MHRA data integrity guidanceData governanceData visualization
About the company
Katalyst CROkatalysthls.com
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
Visa sponsorship history
4 years sponsoring, last filed FY2026
Data powered by U.S. Department of Labor. This does not guarantee sponsorship for this specific role.32H-1B approved
89%approval rate
3new H-1B hires
9PERM certified
$240,000median wage / yr
H-1B Petition ApprovalsVisas USCIS actually granted: the strongest sign the company sponsors.
202319
20249
20254
LCA Certified ApplicationsAn early filing step, not a visa approval: it signals intent, not confirmed sponsorship.
20236
20242
20259
20262
Green Card (PERM) FilingsCertified green card filings: a long-term commitment to international hires.
20235
20241
20253
Top sponsored roles
VALIDATION ENGINEERQUALITY ENGINEERCLINICAL DATA ANALYSTPRODUCT DEVELOPMENT ENGINEERCLINICAL DATA MANAGER
Sponsored employees from
India
Job description
Summary
Katalyst CRO is a company focused on ensuring quality standards and regulatory compliance in computer systems. The Computer System Validation Engineer will collaborate with cross-functional teams to maintain data integrity and manage system lifecycles while optimizing operational efficiency.
Responsibilities
- Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training
- Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies
- Facilitate risk assessments to identify validation deliverables and project requirements
- Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews
- Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports
- Analyze validation data and troubleshoot issues in collaboration with technical teams
- Maintain communication with stakeholders to address system needs, validation progress, and related concerns
Skills
- Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations
- Hands-on experience in validating computerized systems
- Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance
- Ability to work effectively in a dynamic, cross-functional team environment
- Proven expertise in applying data governance measures and creating impactful data visualizations
- Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field
- Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation
Qualifications
Must Haves
- Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations
- Hands-on experience in validating computerized systems
- Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance
- Ability to work effectively in a dynamic, cross-functional team environment
- Proven expertise in applying data governance measures and creating impactful data visualizations
- Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field
Nice to Haves
- Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation