Katalyst CRO
Posted 61 days agoVerified live 14h ago
Process Engineer
Brief overview
Remote
2+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Validation protocols IQValidation protocols OQValidation protocols PQManufacturing process developmentProcess studiesRoot cause analysisPLM systemsFDA regulationsRegulatory complianceMachiningMetal finishingLaser processingProduction automationStatistical data analysisMinitabGeometric Dimensioning and TolerancingMedical device manufacturing
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 providing clinical research services, and they are seeking a Process Engineer to develop and implement manufacturing processes. The role involves writing validation protocols, conducting investigations, and ensuring compliance with FDA regulations.
Responsibilities
- Write and execute validation protocols and reports (IQ, OQ, PQ)
- Develop and implement manufacturing processes, specifications, operator instructions, process studies, and production readiness activities
- Conduct investigations, root cause analysis, problem solving, and prepare reports/presentations
- Update procedures, manufacturing specifications, bills, routes, and travelers for product/process changes in PLM systems
- Work with equipment manufacturers and distributors to develop user requirements
- Partner with Operations, OpEx, Planning, Engineering, and Quality teams to align validation strategy, author documents, coordinate execution, and manage approvals
- Ensure adherence to FDA regulations, regulatory requirements, company policies, and operating procedures
- Identify opportunities for process improvement and implement best practices
- Maintain positive and cooperative communication with employees, customers, contractors, and vendors
Skills
- 2-4 years of experience in manufacturing and/or process engineering
- Strong technical writing skills with awareness of intended audience
- Ability to effectively communicate with operators, peers, and management in both written and oral formats
- Hands-on experience with validation protocols
- Experience in medical device and/or regulated manufacturing environment
- Persuasive communication and strong interpersonal abilities
- Proficiency with Microsoft Office tools
- Background in medical device or other regulated industries
- Experience with machining, metal finishing, laser processing, or production automation
- Practical exposure to machining, casting, finishing, laser processing, or automation
- Knowledge of statistical data analysis tools (e.g., Minitab)
- Basic understanding of Geometric Dimensioning and Tolerancing
- Willingness to support global projects, including travel
Qualifications
Must Haves
- 2-4 years of experience in manufacturing and/or process engineering
- Strong technical writing skills with awareness of intended audience
- Ability to effectively communicate with operators, peers, and management in both written and oral formats
- Hands-on experience with validation protocols
- Experience in medical device and/or regulated manufacturing environment
- Persuasive communication and strong interpersonal abilities
- Proficiency with Microsoft Office tools
- Background in medical device or other regulated industries
- Experience with machining, metal finishing, laser processing, or production automation
- Practical exposure to machining, casting, finishing, laser processing, or automation
- Knowledge of statistical data analysis tools (e.g., Minitab)
- Basic understanding of Geometric Dimensioning and Tolerancing
- Willingness to support global projects, including travel
Benefits
- Work model: remote, onsite