CSV Validation Engineer

Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, and Medical Devices. They are seeking a CSV Validation Engineer responsible for validation strategy, planning, and execution of computer systems in accordance with regulatory requirements.

Responsibilities:

• Define validation Strategy for computerized systems and platforms utilized in GxP Space
• Create Validation deliverables such as Validation Plan, Test Protocols, Traceability matrix and execution of protocols
• Participate in user review meetings, discussions with Quality Assurance and Compliance groups
• Participate/conduct Risk Assessments
• Develop and maintain policies and procedures
• Effectively communicate the validation activities and deliverables to the project team, customer stake holders and global team within Zifo
• Act as a liaison between Zifo remote teams and customers in US & Canada
• Participate in internal initiatives around Computer Systems Validation

Requirements:

• Define validation Strategy for computerized systems and platforms utilized in GxP Space
• Create Validation deliverables such as Validation Plan, Test Protocols, Traceability matrix and execution of protocols
• Participate in user review meetings, discussions with Quality Assurance and Compliance groups
• Participate/conduct Risk Assessments
• Develop and maintain policies and procedures
• Effectively communicate the validation activities and deliverables to the project team, customer stake holders and global team within Zifo
• Act as a liaison between Zifo remote teams and customers in US & Canada
• Participate in internal initiatives around Computer Systems Validation
• Bachelor or Master's degree in Lifesciences or Computer Sciences
• 5+ years' experience with Computer Systems Validation is required for this role
• Strong knowledge of GxP Requirements, GCP regulations, 21 CFR part 11 requirements
• Must have experience with validation of IT infrastructure systems including R, SAS etc
• Experience with GxP systems validation like ELN, LIMS, QMS etc
• Experience with Veeva Vault Systems