myGwork - LGBTQ+ Business Community
Computer System Validation Manager
myGwork - LGBTQ+ Business Community, Cockeysville, Maryland, United States, 21030
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Computer System Validation Manager
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myGwork - LGBTQ+ Business Community This job is with Jabil, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. Summary The CSV Manager will play a critical role in bridging the gap between technical operations and IT functions, ensuring seamless collaboration and communication across cross-functional teams. Responsibilities
Review and approve validation and compliance documents supporting GxP computerized systems. Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls. Ensure that all validation deliverables are met such as protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports, Trace Matrices and Summary Reports associated with validated computer systems. Perform Risk Assessments of the CSV systems with an understanding of applying risk management principles. Review and approve periodic reviews and ongoing support of validated systems post Go-Live. Assess the impact of system changes through change management and change control systems. Develop and maintain Validation SOPs, forms, documentation, and files. Ensure Data Integrity Assessments is completed and Remediation Plans for the identified gap, if any, is developed with an understanding of applying ALCOA+ principles. Qualifications
Ten plus (10+) years of relevant CSV, validation, within a cGMP environment Experience in the biotechnology and/medical or pharmaceutical industry required. Excellent written and verbal communication, Ability to work in a demanding environment. Collaborative with independent work skills and a strong work ethic Microsoft Office and management skills. Minimum of a B.S. in a Life Sciences discipline +5 years of management/subject matter expert experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry +5 years experience in Quality Assurance/Quality Control function including knowledge and application of COMP principles and working in FDA-regulated environment The pay range for this role is $83,400 - $150,200. As part of the total rewards package, Jabil offers benefits to enhance your health, wealth, and resilient self. Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law. If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability.
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Computer System Validation Manager
role at
myGwork - LGBTQ+ Business Community This job is with Jabil, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. Summary The CSV Manager will play a critical role in bridging the gap between technical operations and IT functions, ensuring seamless collaboration and communication across cross-functional teams. Responsibilities
Review and approve validation and compliance documents supporting GxP computerized systems. Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls. Ensure that all validation deliverables are met such as protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports, Trace Matrices and Summary Reports associated with validated computer systems. Perform Risk Assessments of the CSV systems with an understanding of applying risk management principles. Review and approve periodic reviews and ongoing support of validated systems post Go-Live. Assess the impact of system changes through change management and change control systems. Develop and maintain Validation SOPs, forms, documentation, and files. Ensure Data Integrity Assessments is completed and Remediation Plans for the identified gap, if any, is developed with an understanding of applying ALCOA+ principles. Qualifications
Ten plus (10+) years of relevant CSV, validation, within a cGMP environment Experience in the biotechnology and/medical or pharmaceutical industry required. Excellent written and verbal communication, Ability to work in a demanding environment. Collaborative with independent work skills and a strong work ethic Microsoft Office and management skills. Minimum of a B.S. in a Life Sciences discipline +5 years of management/subject matter expert experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry +5 years experience in Quality Assurance/Quality Control function including knowledge and application of COMP principles and working in FDA-regulated environment The pay range for this role is $83,400 - $150,200. As part of the total rewards package, Jabil offers benefits to enhance your health, wealth, and resilient self. Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law. If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability.
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