Katalyst Healthcares and Life Sciences
Validation Engineer - CSV
Katalyst Healthcares and Life Sciences, Decatur, Illinois, United States, 62523
Responsibilities:
Lead and execute Computer System Validation (CSV) projects, ensuring all systems are compliant with regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). Develop and author CSV documentation, including Validation Plans, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Risk Assessments, Test Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports. Perform gap assessments and remediation activities for legacy systems to ensure they meet current regulatory standards. Collaborate with cross-functional teams, including IT, Quality Assurance, Manufacturing, and R&D, to ensure systems are validated and maintained in a state of control. Provide CSV expertise during the selection and implementation of new systems, ensuring that validation activities are integrated into the project lifecycle. Conduct training sessions and workshops for stakeholders on CSV processes and regulatory compliance. Support audits and inspections by regulatory bodies by providing CSV documentation and expertise. Maintain awareness of industry trends and regulatory changes that may impact CSV practices. Requirements:
Bachelor's degree in engineering, Computer Science, Life Sciences, or a related field. Minimum of 5 years of experience in Computer System Validation in the biotech, pharmaceutical, or medical device industry. In-depth knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other relevant regulations and guidelines. Proven experience in authoring and executing validation documents (IQ/OQ/PQ) for various computerized systems, including laboratory systems, manufacturing systems, and enterprise applications. Strong understanding of risk-based validation approaches. Excellent documentation skills with a high level of attention to detail. Strong problem-solving abilities and the capacity to work independently and collaboratively in a fast-paced environment. Excellent communication and interpersonal skills. Experience with Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), and Manufacturing Execution Systems (MES). Previous experience working in a gene therapy or biotechnology environment. Certification in Computer System Validation or related areas is a plus.
Lead and execute Computer System Validation (CSV) projects, ensuring all systems are compliant with regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). Develop and author CSV documentation, including Validation Plans, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Risk Assessments, Test Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports. Perform gap assessments and remediation activities for legacy systems to ensure they meet current regulatory standards. Collaborate with cross-functional teams, including IT, Quality Assurance, Manufacturing, and R&D, to ensure systems are validated and maintained in a state of control. Provide CSV expertise during the selection and implementation of new systems, ensuring that validation activities are integrated into the project lifecycle. Conduct training sessions and workshops for stakeholders on CSV processes and regulatory compliance. Support audits and inspections by regulatory bodies by providing CSV documentation and expertise. Maintain awareness of industry trends and regulatory changes that may impact CSV practices. Requirements:
Bachelor's degree in engineering, Computer Science, Life Sciences, or a related field. Minimum of 5 years of experience in Computer System Validation in the biotech, pharmaceutical, or medical device industry. In-depth knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other relevant regulations and guidelines. Proven experience in authoring and executing validation documents (IQ/OQ/PQ) for various computerized systems, including laboratory systems, manufacturing systems, and enterprise applications. Strong understanding of risk-based validation approaches. Excellent documentation skills with a high level of attention to detail. Strong problem-solving abilities and the capacity to work independently and collaboratively in a fast-paced environment. Excellent communication and interpersonal skills. Experience with Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), and Manufacturing Execution Systems (MES). Previous experience working in a gene therapy or biotechnology environment. Certification in Computer System Validation or related areas is a plus.