Katalyst CRO
Posted 23 days agoVerified live 13h ago
Manufacturing Process Engineer
Brief overview
Remote
UndergradOr in progress
2+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Mechanical systemsElectrical troubleshootingSemi-automated manufacturing equipmentRoot cause analysisValidation processes (IQ/OQ/PQ)Quality systemsLeanSix SigmaManufacturing Execution Systems (MES)SAPMedical device manufacturingOwnership and accountability
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 Manufacturing Process Engineer to enhance their manufacturing processes within a regulated environment. The role involves improving equipment performance, troubleshooting issues, and ensuring compliance with quality standards.
Responsibilities
- Maintain and continuously improve established manufacturing processes, tooling, and semi-automated systems
- Own equipment performance, reliability, and long-term sustainability
- Troubleshoot mechanical and electrical issues using structured root cause methodologies
- Drive equipment and process improvements, including error-proofing and uptime optimization
- Execute validation activities (IQ/OQ/PQ) and maintain technical documentation
- Ensure compliance with FDA, ISO, and internal quality system requirements
- Support CAPA, nonconformance investigations, and audit readiness
- Provide real-time production support and drive continuous improvement initiatives
- Train and guide technicians and operators on processes and equipment
Skills
- Bachelor's degree in mechanical, Electrical, or related Engineering discipline
- 2+ years of engineering experience in a regulated manufacturing environment
- Hands-on experience with mechanical systems, equipment, and tooling
- Electrical troubleshooting and controls fundamentals
- Experience supporting or owning semi-automated manufacturing equipment
- Strong problem-solving and root cause analysis capability
- Medical device manufacturing experience
- Experience with validation processes (IQ/OQ/PQ) and quality systems
- Lean / Six Sigma experience
- Exposure to manufacturing systems (e.g., MES, SAP)
- Basic familiarity with automated equipment and controls
Qualifications
Must Haves
- Bachelor's degree in mechanical, Electrical, or related Engineering discipline
- 2+ years of engineering experience in a regulated manufacturing environment
- Hands-on experience with mechanical systems, equipment, and tooling
- Electrical troubleshooting and controls fundamentals
- Experience supporting or owning semi-automated manufacturing equipment
- Strong problem-solving and root cause analysis capability
- Medical device manufacturing experience
- Experience with validation processes (IQ/OQ/PQ) and quality systems
- Lean / Six Sigma experience
- Exposure to manufacturing systems (e.g., MES, SAP)
- Basic familiarity with automated equipment and controls
Benefits
- Work model: remote, onsite