Katalyst CRO
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Sr. Validation Engineer (CSV)
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Katalyst CRO 5 months ago Be among the first 25 applicants Join to apply for the
Sr. Validation Engineer (CSV)
role at
Katalyst CRO Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remediation activities. Investigate and resolve non-conformances, deviations, CAPAs, and change controls. Participate in internal/external software audits. Contribute to process improvements and documentation.
Responsibilities
Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remediation activities. Investigate and resolve non-conformances, deviations, CAPAs, and change controls. Participate in internal/external software audits. Contribute to process improvements and documentation.
Requirements:
Bachelor's/Master's in Computer Science/Engineering. 10+ years in CSV in regulated industries (pharma, biotech, medical device). Proficiency in SDLC, change management, validation techniques. Experience with GAMP 5, FDA 21 CFR Part 11, EU GMP, ISO standards. Project management and leadership experience. Familiar with Quality Management, Document Management, and Validation Management Systems. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Validation Engineer” roles.
Riverside, CA $110,000.00-$150,000.00 19 hours ago Client Development Lead, Validation and Regulatory Compliance
Pasadena, CA $160,000.00-$230,000.00 6 days ago Engineering Manager - Emissions and OBD Validation
Collibra Administrator - Data Governance (Programmer Sr)
Orange, CA $99,902.00-$159,843.00 1 week ago Pomona, CA $91,100.00-$136,700.00 4 days ago Pomona, CA $95,000.00-$115,000.00 3 days ago Riverside, CA $105,000.00-$120,000.00 1 week ago Fullerton, CA $75,000.00-$95,000.00 3 hours ago Pomona, CA $85,000.00-$115,000.00 3 days ago City of Industry, CA $90,000.00-$120,000.00 5 days ago Quality Engineer/Aerospace Manufacturing
Fullerton, CA $75,000.00-$95,000.00 1 week ago La Verne, CA $123,930.00-$160,380.00 3 weeks ago Bell Gardens, CA $100,000.00-$115,000.00 3 days ago Quality Engineer/Aerospace Manufacturing
Orange County, CA $96,000.00-$125,000.00 1 week ago Quality Engineer (Direct Hire or 1-year Consultant option)
Pasadena, CA $90,000.00-$130,000.00 2 days ago Commerce, CA $72,000.00-$80,000.00 2 weeks ago City of Industry, CA $69,000.00-$98,500.00 2 weeks ago Commerce, CA $80,000.00-$95,000.00 2 weeks ago Quality Assurance & Quality Control Engineer II
Commerce, CA $80,000.00-$95,000.00 2 weeks ago Quality Engineer (Direct Hire or 1-year Consultant option)
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Sr. Validation Engineer (CSV)
role at
Katalyst CRO 5 months ago Be among the first 25 applicants Join to apply for the
Sr. Validation Engineer (CSV)
role at
Katalyst CRO Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remediation activities. Investigate and resolve non-conformances, deviations, CAPAs, and change controls. Participate in internal/external software audits. Contribute to process improvements and documentation.
Responsibilities
Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remediation activities. Investigate and resolve non-conformances, deviations, CAPAs, and change controls. Participate in internal/external software audits. Contribute to process improvements and documentation.
Requirements:
Bachelor's/Master's in Computer Science/Engineering. 10+ years in CSV in regulated industries (pharma, biotech, medical device). Proficiency in SDLC, change management, validation techniques. Experience with GAMP 5, FDA 21 CFR Part 11, EU GMP, ISO standards. Project management and leadership experience. Familiar with Quality Management, Document Management, and Validation Management Systems. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Validation Engineer” roles.
Riverside, CA $110,000.00-$150,000.00 19 hours ago Client Development Lead, Validation and Regulatory Compliance
Pasadena, CA $160,000.00-$230,000.00 6 days ago Engineering Manager - Emissions and OBD Validation
Collibra Administrator - Data Governance (Programmer Sr)
Orange, CA $99,902.00-$159,843.00 1 week ago Pomona, CA $91,100.00-$136,700.00 4 days ago Pomona, CA $95,000.00-$115,000.00 3 days ago Riverside, CA $105,000.00-$120,000.00 1 week ago Fullerton, CA $75,000.00-$95,000.00 3 hours ago Pomona, CA $85,000.00-$115,000.00 3 days ago City of Industry, CA $90,000.00-$120,000.00 5 days ago Quality Engineer/Aerospace Manufacturing
Fullerton, CA $75,000.00-$95,000.00 1 week ago La Verne, CA $123,930.00-$160,380.00 3 weeks ago Bell Gardens, CA $100,000.00-$115,000.00 3 days ago Quality Engineer/Aerospace Manufacturing
Orange County, CA $96,000.00-$125,000.00 1 week ago Quality Engineer (Direct Hire or 1-year Consultant option)
Pasadena, CA $90,000.00-$130,000.00 2 days ago Commerce, CA $72,000.00-$80,000.00 2 weeks ago City of Industry, CA $69,000.00-$98,500.00 2 weeks ago Commerce, CA $80,000.00-$95,000.00 2 weeks ago Quality Assurance & Quality Control Engineer II
Commerce, CA $80,000.00-$95,000.00 2 weeks ago Quality Engineer (Direct Hire or 1-year Consultant option)
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