Katalyst CRO
Posted 67 days agoVerified live 2d ago
CSV Engineer
Brief overview
Remote
UndergradOr in progress
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Computer System Validation (CSV)GAMP 521 CFR Part 11GMP regulationsQC laboratory systems validationManufacturing equipment validationValidation lifecycle documentationUser Requirements Specifications (URS)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Risk AssessmentsValidation ReportsRisk-based validation
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 (CSV) Engineer with experience in GMP-regulated environments. The role involves developing and maintaining validation documentation, supporting the validation lifecycle, and ensuring compliance with regulatory standards.
Responsibilities
- Develop, execute, and maintain Computer System Validation (CSV) documentation and validation protocols for QC laboratory systems and manufacturing systems
- Support the complete validation lifecycle, including preparation, execution, review, and approval of User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Risk Assessments, and Validation Reports
- Perform risk assessments to identify and mitigate validation and compliance risks
- Ensure compliance with GAMP 5, 21 CFR Part 11, GMP, and internal quality standards
- Review validation documentation to ensure accuracy, completeness, and regulatory compliance
- Collaborate with Quality Assurance (QA), Manufacturing, Engineering, and IT teams to support validation activities and system implementations
- Provide validation support for QC laboratory systems and manufacturing equipment throughout their lifecycle
- Assist with change control, deviation investigations, and periodic reviews related to validated systems
- Maintain accurate validation records and ensure documentation is audit ready
- Support internal and external regulatory inspections by providing validation documentation and technical expertise
Skills
- Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or a related field
- Experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment
- Strong knowledge of GAMP 5, 21 CFR Part 11, and GMP regulations
- Hands-on experience supporting QC laboratory systems and/or manufacturing equipment validation
- Experience developing and reviewing validation lifecycle documentation, including URS, IQ, OQ, PQ, Risk Assessments, and Validation Reports
- Experience working collaboratively with Quality Assurance (QA), Manufacturing, Engineering, and IT teams
- Strong understanding of the CSV lifecycle, risk-based validation, and documentation best practices
- Excellent technical writing, documentation, communication, and problem-solving skills
- Ability to manage multiple validation activities while maintaining compliance with regulatory and quality requirements
Qualifications
Must Haves
- Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or a related field
- Experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment
- Strong knowledge of GAMP 5, 21 CFR Part 11, and GMP regulations
- Hands-on experience supporting QC laboratory systems and/or manufacturing equipment validation
- Experience developing and reviewing validation lifecycle documentation, including URS, IQ, OQ, PQ, Risk Assessments, and Validation Reports
- Experience working collaboratively with Quality Assurance (QA), Manufacturing, Engineering, and IT teams
- Strong understanding of the CSV lifecycle, risk-based validation, and documentation best practices
- Excellent technical writing, documentation, communication, and problem-solving skills
- Ability to manage multiple validation activities while maintaining compliance with regulatory and quality requirements