Katalyst CRO
Posted 23 days agoVerified live 1d ago
CSV Specialist
Brief overview
Remote
UndergradOr in progress
3+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Computer System Validation (CSV)GAMP 5FDA 21 CFR Part 11GMPData Integrity (ALCOA+)Validation DocumentationTesting ActivitiesElectronic Quality Management SystemsElectronic Document Management SystemsTrackWiseVeevaSAPLIMSMESEmpowerSharePointServiceNow
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 CSV Specialist to support Computer System Validation activities for GxP-regulated systems in the pharmaceutical, biotechnology, or medical device industry. The role involves ensuring computerized systems are validated and compliant with regulatory requirements and company procedures.
Responsibilities
- Execute and support Computer System Validation (CSV) activities for GxP systems
- Develop, review, and maintain validation documentation, including: Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ Protocols, Validation Reports
- Perform system impact assessments and risk-based validation activities
- Support testing activities, including protocol execution and defect tracking
- Ensure compliance with FDA 21 CFR Part 11, GAMP 5, GMP, and Data Integrity requirements
- Collaborate with Business, IT, QA, and Engineering teams throughout the system lifecycle
- Support change controls, deviations, CAPAs, and periodic reviews
- Maintain validation records within electronic document management systems
- Participate in internal audits and regulatory inspections
Skills
- Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field
- 3+ years of CSV experience in a regulated pharmaceutical, biotechnology, or medical device environment
- Knowledge of GAMP 5, FDA 21 CFR Part 11, GMP, and Data Integrity (ALCOA+) principles
- Experience with validation documentation and testing activities
- Familiarity with electronic quality management and document management systems
- Strong technical writing and communication skills
- Experience with CSA (Computer Software Assurance) methodologies
- Knowledge of systems such as: TrackWise, Veeva, SAP, LIMS, MES, Empower, SharePoint, ServiceNow, Jira
- Experience supporting regulatory audits and inspections
Qualifications
Must Haves
- Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field
- 3+ years of CSV experience in a regulated pharmaceutical, biotechnology, or medical device environment
- Knowledge of GAMP 5, FDA 21 CFR Part 11, GMP, and Data Integrity (ALCOA+) principles
- Experience with validation documentation and testing activities
- Familiarity with electronic quality management and document management systems
- Strong technical writing and communication skills
Nice to Haves
- Experience with CSA (Computer Software Assurance) methodologies
- Knowledge of systems such as: TrackWise, Veeva, SAP, LIMS, MES, Empower, SharePoint, ServiceNow, Jira
- Experience supporting regulatory audits and inspections