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Computer Systems Validation Engineer

TalentBurst, Inc. Sunnyvale, CA
  • Expired: 18 days ago. Applications are no longer accepted.
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

TalentBurst, Inc.


Sunnyvale, CA
94086 USA