Katalyst CRO
Posted 22 days agoVerified live 1d ago
CSV Engineer
Brief overview
Remote
UndergradOr in progress
2+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Computer System ValidationValidation PlansIQ/OQ/PQ ProtocolsValidation ReportsRisk AssessmentRegulatory Requirements - FDARegulatory Requirements - EMAGAMP 5ERP ValidationLIMS ValidationMES ValidationSoftware Development Lifecycle (SDLC)Functional Requirements Specification (FRS)Configuration Specification (CS)Electronic Records and Electronic Signatures (ERES)Data Integrity AssessmentBlue Mountain RAM
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 computer system validation, and they are seeking a CSV Engineer. The role involves developing validation strategies, creating documentation, and ensuring compliance with regulatory requirements.
Responsibilities
- Develop and implement validation strategies for computer systems and software applications
- Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports
- Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements
- Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems
- Conduct validation testing and review test results to ensure systems meet specified requirements
- Provide training and support to staff on validation processes and procedures
- Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance
- Participate in audits and inspections by regulatory agencies
- Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, Client, EMS, & PCS
- Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards
- Assist site Automation groups in configuring I/O and executing CSV protocol requirements
- Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report
Skills
- Bachelor's degree in Computer Science, Engineering, or a related field
- Minimum of 2-5 years of experience in computer system validation or a related field
- Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5)
- Experience with validation of various types of systems, including ERP, LIMS, and MES
- Excellent documentation and technical writing skills
- Strong analytical and problem-solving abilities
- Ability to work independently and as part of a team
- Excellent communication and interpersonal skills
- Certification in Computer System Validation or related areas
- Experience with cloud-based systems and software validation, experience with Blue Mountain RAM
- 3+ years of work experience with Computer System Validation
- 3+ years of Biotechnology Research experience
Qualifications
Must Haves
- Bachelor's degree in Computer Science, Engineering, or a related field
- Minimum of 2-5 years of experience in computer system validation or a related field
- Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5)
- Experience with validation of various types of systems, including ERP, LIMS, and MES
- Excellent documentation and technical writing skills
- Strong analytical and problem-solving abilities
- Ability to work independently and as part of a team
- Excellent communication and interpersonal skills
Nice to Haves
- Certification in Computer System Validation or related areas
- Experience with cloud-based systems and software validation, experience with Blue Mountain RAM
- 3+ years of work experience with Computer System Validation
- 3+ years of Biotechnology Research experience
Benefits
- Work_model: remote or onsite