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