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Computer Systems Validation Engineer

Maxonic Sunnyvale, CA
  • Expired: over a month ago. Applications are no longer accepted.

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.


Why Work Here?

Our focus is to ensure your success, providing you with customized support in order to give wings to your career aspirations.

About Maxonic: Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long term career needs of our candidates. We take pride in the over 5,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.


Sunnyvale, CA