Katalyst CRO
Overview
The Computerized Systems Validation (CSV) position ensures that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP), international guidelines (e.g., 21 CFR Part 11 and Annex 11), and company standards by validating their functionality throughout their lifecycle. Responsibilities include developing and reviewing validation documentation, performing risk and impact assessments, coordinating testing, managing change controls, and supporting audits to maintain the validated status of systems such as ERP, MES, and LIMS.
Responsibilities
Documentation & Planning: Author, review, and approve CSV lifecycle documents, including validation plans, user requirements specifications (URS), risk assessments, protocols, and reports. Validation Execution: Coordinate and execute testing activities, such as User Acceptance Testing (UAT), System Integration Testing (SIT), and Installation, Operational, and Performance Qualifications (IQ, OQ, PQ). Regulatory Compliance: Ensure all computer systems comply with cGMP, 21 CFR Part 11, Annex 11, and other global regulatory requirements. System Lifecycle Management: Oversee the entire CSV lifecycle, from design and development to testing and ongoing maintenance of the validated status of systems. Change Control: Manage change controls, deviations, and non-conformances related to CSV to ensure continuous compliance. Cross-Functional Collaboration: Work with Quality Assurance (QA), automation teams, stakeholders, and vendors to achieve project goals. Audits & Inspections: Support internal and external audits, including FDA inspections, by providing documentation and expertise on CSV activities. Data Integrity: Perform data integrity assessments for computer and automation systems to ensure data is accurate and reliable. Requirements
A bachelor’s degree in a technical, scientific, or related field (e.g., Engineering, Biology, Chemistry) is typically required or preferred. Master’s degrees in related fields (e.g., Information Management, Information Technology, Computer Science) are sometimes preferred. Experience: Significant experience (often 9+ years) in Computerized System Validation (CSV) within the pharmaceutical or medical device industry. Knowledge: Thorough understanding of cGMP regulations, the software development lifecycle (SDLC), and CSV principles, especially 21 CFR Part. Software/System Experience: Familiarity with GxP systems like ERP, MES, LIMS, and automation platforms such as DeltaV. Technical Skills: Strong documentation skills, experience with validation management software (e.g., Kneat), and knowledge of data integrity and cybersecurity principles. Soft Skills: Excellent communication, leadership, and ability to collaborate effectively in cross-functional, global teams.
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Documentation & Planning: Author, review, and approve CSV lifecycle documents, including validation plans, user requirements specifications (URS), risk assessments, protocols, and reports. Validation Execution: Coordinate and execute testing activities, such as User Acceptance Testing (UAT), System Integration Testing (SIT), and Installation, Operational, and Performance Qualifications (IQ, OQ, PQ). Regulatory Compliance: Ensure all computer systems comply with cGMP, 21 CFR Part 11, Annex 11, and other global regulatory requirements. System Lifecycle Management: Oversee the entire CSV lifecycle, from design and development to testing and ongoing maintenance of the validated status of systems. Change Control: Manage change controls, deviations, and non-conformances related to CSV to ensure continuous compliance. Cross-Functional Collaboration: Work with Quality Assurance (QA), automation teams, stakeholders, and vendors to achieve project goals. Audits & Inspections: Support internal and external audits, including FDA inspections, by providing documentation and expertise on CSV activities. Data Integrity: Perform data integrity assessments for computer and automation systems to ensure data is accurate and reliable. Requirements
A bachelor’s degree in a technical, scientific, or related field (e.g., Engineering, Biology, Chemistry) is typically required or preferred. Master’s degrees in related fields (e.g., Information Management, Information Technology, Computer Science) are sometimes preferred. Experience: Significant experience (often 9+ years) in Computerized System Validation (CSV) within the pharmaceutical or medical device industry. Knowledge: Thorough understanding of cGMP regulations, the software development lifecycle (SDLC), and CSV principles, especially 21 CFR Part. Software/System Experience: Familiarity with GxP systems like ERP, MES, LIMS, and automation platforms such as DeltaV. Technical Skills: Strong documentation skills, experience with validation management software (e.g., Kneat), and knowledge of data integrity and cybersecurity principles. Soft Skills: Excellent communication, leadership, and ability to collaborate effectively in cross-functional, global teams.
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