Job-ID32462365Reference26-01007 Job Summary: We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications. The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle. The primary responsibility is to ensure that validation activities supporting Manufacturing Execution Systems (MES) are documented in accordance with applicable procedures and regulatory requirements. Roles & Responsibilities: Author, review, and/or approve applicable CSV documentation. Assist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures. Assist Business Owners and Technical Owners in developing requirements and specifications for computerized systems used in GxP operations. Support validation activities for Manufacturing Execution Systems (MES). Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs. Ensure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices. Support validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments. Utilize IT service management platforms to support incident, problem, and change management activities. Work with Business Quality Management Systems and related validation processes. Education & Experience: Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience. Minimum 4+ years of direct experience in Computer System Validation (CSV). Strong knowledge of GAMP and risk-based validation approaches. Good understanding of electronic records and electronic signatures. Strong knowledge of Manufacturing Execution System (MES) validation. Familiarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch. Strong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs. Knowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing. Experience with IT service management platforms such as ServiceNow. Exposure to Business Quality Management Systems such as Veeva.
...Job Description Job Description Mindful Measures, Inc. is currently seeking a UI/UX Designer to join our team! This individual will be responsible for designing graphics and user experience/interface for our products. This individual will have an immediate impact...
...innovative, cost-effective solutions and services that enable our customers to rapidly adapt to dynamic environments. As a Lead Consultant, ServiceNow , you will play a vital role at Nuvitek. You will work closely with an equally enthusiastic team of developers and...
...Credentialing Specialist (Dental / Healthcare) Location: Remote Type: Full-Time Schedule: Must have overlap with U.S. business hours... ...credentialing trackers using Excel Assist with audits and compliance documentation as needed Support internal operational workflows...
Kaiser Permanente is seeking an MSW to help build and enhance the Systeme.io all-in-one marketing platform. In this role, you will design, develop, and maintain scalable, secure software powering entrepreneurs worldwide. Youll collaborate closely with product, design,...
...Bookkeeper/Accounting Assistant Onsite (Ptree City/Newnan Area) Our client located in the Newnan/Peachtree City area is looking to... ...closing procedures. Qualifications: Minimum 2 years of experience in Accounting/Bookkeeping Proven expertise in QuickBooks...