Katalyst Healthcares and Life Sciences
Lab Instruments Software Validation Analyst / Technical Writer
Katalyst Healthcares and Life Sciences, Jersey City, New Jersey, United States, 07390
Responsibilities: -
Validation Planning & Execution: - Develop, review, and execute validation protocols (DQ, IQ, OQ, PQ) for laboratory instruments and computerized systems. Support integration, regression, and performance testing of software and equipment. Participate in validation execution in GxP-regulated facilities. Documentation & Compliance: - Prepare and maintain validation life cycle documentation including URS, FRS, Risk Assessments, Traceability Matrix, SOPs, and Validation Summary Reports. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, and GAMP 5 guidelines. Contribute to periodic reviews and revalidation processes for laboratory systems. Risk Management & CAPA: - Conduct risk assessments and gap analyses to identify potential issues. ssist in deviation investigations and support Corrective and Preventive Actions (CAPA) implementation. Collaboration & Continuous Improvement: - Work closely with Quality Assurance, R&D, Production, and IT teams to deliver validation deliverables. Collaborate with hardware/software development teams on troubleshooting and debugging activities. Recommend process improvements and contribute to updates of SOPs and validation practices. Requirements: -
Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or related discipline required. Master's degree or professional certifications in Computer System Validation (CSV), GAMP 5, or Regulatory Compliance preferred. 06 - 09 years of experience in laboratory instruments and software validation within clinical research, pharmaceutical, or biotechnology environment. 03 - 05 years of specialized experience in the following areas: - Validation of analytical instrument systems (e.g., spectroscopy, chromatography, protein analysers, PCR systems, sequencers). Equipment qualification (DQ, IQ, OQ, PQ). Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5. Validation documentation authoring (Validation Plans, URS/FRS, Risk Assessments, Traceability Matrix, Validation Reports). Risk management and CAPA support for validated systems. Strong technical writing, analytical, and communication skills. bility to work in global, cross-functional team environments and deliver on multiple projects concurrently. We are seeking a Lab Instruments Software Validation Analyst with 06 - 09 years of progressive experience in the clinical research, pharmaceutical, or biotechnology industry. The successful candidate will be responsible for ensuring the reliability, accuracy, and regulatory compliance of laboratory instruments and software systems used in clinical trials. This role requires a strong technical background in validation methodologies, regulatory compliance, and equipment qualification, along with the ability to collaborate effectively with cross-functional teams. The candidate should bring at least 03 - 05 years of focused, hands-on expertise in specialized validation skill areas.
Validation Planning & Execution: - Develop, review, and execute validation protocols (DQ, IQ, OQ, PQ) for laboratory instruments and computerized systems. Support integration, regression, and performance testing of software and equipment. Participate in validation execution in GxP-regulated facilities. Documentation & Compliance: - Prepare and maintain validation life cycle documentation including URS, FRS, Risk Assessments, Traceability Matrix, SOPs, and Validation Summary Reports. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, and GAMP 5 guidelines. Contribute to periodic reviews and revalidation processes for laboratory systems. Risk Management & CAPA: - Conduct risk assessments and gap analyses to identify potential issues. ssist in deviation investigations and support Corrective and Preventive Actions (CAPA) implementation. Collaboration & Continuous Improvement: - Work closely with Quality Assurance, R&D, Production, and IT teams to deliver validation deliverables. Collaborate with hardware/software development teams on troubleshooting and debugging activities. Recommend process improvements and contribute to updates of SOPs and validation practices. Requirements: -
Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or related discipline required. Master's degree or professional certifications in Computer System Validation (CSV), GAMP 5, or Regulatory Compliance preferred. 06 - 09 years of experience in laboratory instruments and software validation within clinical research, pharmaceutical, or biotechnology environment. 03 - 05 years of specialized experience in the following areas: - Validation of analytical instrument systems (e.g., spectroscopy, chromatography, protein analysers, PCR systems, sequencers). Equipment qualification (DQ, IQ, OQ, PQ). Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5. Validation documentation authoring (Validation Plans, URS/FRS, Risk Assessments, Traceability Matrix, Validation Reports). Risk management and CAPA support for validated systems. Strong technical writing, analytical, and communication skills. bility to work in global, cross-functional team environments and deliver on multiple projects concurrently. We are seeking a Lab Instruments Software Validation Analyst with 06 - 09 years of progressive experience in the clinical research, pharmaceutical, or biotechnology industry. The successful candidate will be responsible for ensuring the reliability, accuracy, and regulatory compliance of laboratory instruments and software systems used in clinical trials. This role requires a strong technical background in validation methodologies, regulatory compliance, and equipment qualification, along with the ability to collaborate effectively with cross-functional teams. The candidate should bring at least 03 - 05 years of focused, hands-on expertise in specialized validation skill areas.