Katalyst CRO
Posted 58 days agoVerified live 9h ago
Process Validation Engineer
Brief overview
Remote
UndergradOr in progress
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Equipment QualificationValidationRegulatory ComplianceKneat Digital PlatformDocument Management SystemsComputer Systems Validation (CSV)Temperature Mapping MethodologiesEllab 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 a company specializing in clinical research and development services. They are seeking a Process Validation Engineer to ensure compliance with regulatory standards and manage validation processes.
Responsibilities
- Experience with equipment qualification, validation, or regulatory compliance
- Familiarity with Kneat digital platform or similar document management systems
- Strong understanding of CSV (Computer Systems Validation) principles
- Knowledge of temperature mapping methodologies
- Familiarity with Ellab systems or similar validation equipment
Skills
- Bachelor's degree in Engineering, Science, or related field
- Experience with equipment qualification, validation, or regulatory compliance
- Familiarity with Kneat digital platform or similar document management systems
- Strong understanding of CSV (Computer Systems Validation) principles
- Knowledge of temperature mapping methodologies
- Familiarity with Ellab systems or similar validation equipment
Qualifications
Must Haves
- Bachelor's degree in Engineering, Science, or related field
- Experience with equipment qualification, validation, or regulatory compliance
- Familiarity with Kneat digital platform or similar document management systems
- Strong understanding of CSV (Computer Systems Validation) principles
- Knowledge of temperature mapping methodologies
- Familiarity with Ellab systems or similar validation equipment
Benefits
- Work_model: [remote, onsite]