Expired: 3 days ago. Applications are no longer accepted.
Our client, a medical device company in Sunnyvale, CA is seeking a Computer Systems ValidationEngineer.
Contract Role: 1 year with possible extension
Description: Computer Systems Validation Engineer to assist projects in providing expertise in ensuring regulatory compliance across the IT projects and systems.
Roles and Responsibilities:
• Maintains responsibilities for ensuring GxP computerized systems operate within the framework of regulations (GxP, 21CFR11, etc.), applicable Quality Modules, and requirements defined in local procedures. • Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met. • Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs). • Review CSV Validation activities including deliverables from regulatory compliance standpoint. • Provide support to external and internal audits related to computerized system validation activities. • Advice a cross functional team in an efficient manner, including but not limited to excellent communication and time management skills to share responsibilities and expectations, and accomplishing goals throughout timelines. • Help, establish and sustain computer system validation global policies and standards that incorporate industry best practices and are health authority compliant. • Partnering with internal and external teams; sharing information to increase the collective understanding of QA and Compliance programs. • Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5. • Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external). • Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions. • Authoring and /or revising SOPs. • Ability to provide guidance on revising validation documents and protocols. • Administer applicable electronic systems. • Assist as needed in audits and inspections. • Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations. • Contribute to projects related to CSV improvements. • Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.
Must Have: Experience in 21 CFR Part 11, Part 820, Annex 11, GAMP5
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