Katalyst CRO
Component EngineerValidation (IQ/OQ/PQ)
Katalyst CRO, Irvine, California, United States, 92713
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Component Engineer Validation (IQ/OQ/PQ)
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Katalyst CRO 2 days ago Be among the first 25 applicants Join to apply for the
Component Engineer Validation (IQ/OQ/PQ)
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Katalyst CRO Get AI-powered advice on this job and more exclusive features. Job Description
Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards. Component validation activities including creation and execution of IQ/OQ/PQ protocols and reports. Collaborate with cross-functional teams (QA, R&D, Manufacturing) to evaluate and qualify new components. Conduct risk assessments (FMEA) and support design and process changes. Coordinate with suppliers for part approval, PPAPs, and validation documentation. Ensure all validations meet regulatory compliance (21 CFR Part 820, EU MDR, ISO 14971.) Support CAPA and non-conformance investigations related to component failures. Validation protocols (IQ, OQ, PQ.). Component qualification and material review. Regulatory knowledge (FDA, ISO 13485, cGMP.) Root cause analysis, CAPA. Supplier qualification and audits. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Biotechnology Research and Civil Engineering Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Component Engineer” roles.
Tustin, CA $107,800.00-$134,800.00 1 week ago Long Beach, CA $120,000.00-$148,000.00 2 weeks ago Tustin, CA $96,700.00-$120,900.00 2 weeks ago Irvine, CA $125,000.00-$169,800.00 2 weeks ago Long Beach, CA $176,000.00-$225,500.00 2 weeks ago Long Beach, CA $142,000.00-$181,500.00 2 weeks ago Irvine, CA $125,000.00-$169,800.00 1 week ago Tustin, CA $121,500.00-$151,900.00 2 weeks ago Manufacturing Engineer - New Product Introduction (NPI)
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Component Engineer Validation (IQ/OQ/PQ)
role at
Katalyst CRO 2 days ago Be among the first 25 applicants Join to apply for the
Component Engineer Validation (IQ/OQ/PQ)
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Job Description
Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards. Component validation activities including creation and execution of IQ/OQ/PQ protocols and reports. Collaborate with cross-functional teams (QA, R&D, Manufacturing) to evaluate and qualify new components. Conduct risk assessments (FMEA) and support design and process changes. Coordinate with suppliers for part approval, PPAPs, and validation documentation. Ensure all validations meet regulatory compliance (21 CFR Part 820, EU MDR, ISO 14971.) Support CAPA and non-conformance investigations related to component failures. Validation protocols (IQ, OQ, PQ.). Component qualification and material review. Regulatory knowledge (FDA, ISO 13485, cGMP.) Root cause analysis, CAPA. Supplier qualification and audits. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Biotechnology Research and Civil Engineering Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Component Engineer” roles.
Tustin, CA $107,800.00-$134,800.00 1 week ago Long Beach, CA $120,000.00-$148,000.00 2 weeks ago Tustin, CA $96,700.00-$120,900.00 2 weeks ago Irvine, CA $125,000.00-$169,800.00 2 weeks ago Long Beach, CA $176,000.00-$225,500.00 2 weeks ago Long Beach, CA $142,000.00-$181,500.00 2 weeks ago Irvine, CA $125,000.00-$169,800.00 1 week ago Tustin, CA $121,500.00-$151,900.00 2 weeks ago Manufacturing Engineer - New Product Introduction (NPI)
Irvine, CA $104,000.00-$162,000.00 8 months ago Tustin, CA $121,500.00-$151,900.00 2 weeks ago Senior Manufacturing Engineer, Vehicle Components
Long Beach, CA $130,000.00-$166,000.00 1 week ago Long Beach, CA $146,000.00-$187,000.00 2 weeks ago Irvine, CA $95,000.00-$100,000.00 3 hours ago Long Beach, CA $97,000.00-$124,300.00 2 weeks ago Huntington Beach, CA $80,000.00-$140,000.00 1 month ago Long Beach, CA $75,000.00-$95,000.00 5 days ago Senior Manufacturing Engineer - New Product Introduction (NPI)
Senior Spacecraft Mechanical Engineer I/II
Irvine, CA $112,700.00-$168,500.00 1 week ago Senior Vehicle Accessory Product Development Engineer
Newport Beach, CA $28.00-$42.00 1 week ago Irvine, CA $160,000.00-$180,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr