Katalyst CRO
Posted 76 days agoVerified live 8h ago
Computer System Validation Engineer
Brief overview
Remote
UndergradOr in progress
4+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Computer System Validation (CSV)GAMPRisk-based validationElectronic records and electronic signaturesManufacturing Execution System (MES) validationEmerson SyncadeSAPOracle ERPInfoBatchCSV documentationValidation PlansRequirements specificationTest Scripts (IQ/OQ/PQ)Trace MatricesStandard Operating Procedures (SOPs)Pharmaceutical manufacturing systemsLaboratory systems
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 seeking a Computer System Validation Engineer for a global pharmaceutical client. This role involves leading and executing validation activities for GxP electronic systems and applications, ensuring compliance with regulatory requirements and documentation standards.
Responsibilities
- 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 in developing requirements and specifications for computerized systems used in GxP operations
- Support validation activities for Manufacturing Execution Systems (MES)
- Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs
- Ensure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices
- Support validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments
- Utilize IT service management platforms to support incident, problem, and change management activities
- Work with Business Quality Management Systems and related validation processes
Skills
- Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience
- Minimum 4+ years of direct experience in Computer System Validation (CSV)
- Strong knowledge of GAMP and risk-based validation approaches
- Good understanding of electronic records and electronic signatures
- Strong knowledge of Manufacturing Execution System (MES) validation
- Familiarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch
- Strong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs
- Knowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing
- Experience with IT service management platforms such as ServiceNow
- Exposure to Business Quality Management Systems such as Veeva
Qualifications
Must Haves
- Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience
- Minimum 4+ years of direct experience in Computer System Validation (CSV)
- Strong knowledge of GAMP and risk-based validation approaches
- Good understanding of electronic records and electronic signatures
- Strong knowledge of Manufacturing Execution System (MES) validation
- Familiarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch
- Strong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs
- Knowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing
- Experience with IT service management platforms such as ServiceNow
- Exposure to Business Quality Management Systems such as Veeva