NEWPosted 1 hour ago
Job ID: JOB_ID_8496
About the Job
The CSV Validation Engineer is responsible for developing and executing validation strategies and plans for computer systems and infrastructure components. This role ensures compliance with applicable policies, procedures, and regulatory requirements within the GxP space.
Key Responsibilities:
- Define validation strategy for computerized systems and platforms utilized in GxP environments.
- Create essential validation deliverables, including Validation Plans, Test Protocols, and Traceability Matrices.
- Execute validation protocols and document results meticulously.
- Participate actively in user review meetings and engage in discussions with Quality Assurance and Compliance groups.
- Conduct and participate in Risk Assessments related to system validation.
- Develop and maintain policies and procedures pertaining to computer systems validation.
- Effectively communicate validation activities, progress, and deliverables to project teams, customer stakeholders, and global teams within Zifo.
- Act as a liaison between Zifo remote teams and customers located in the US and Canada.
- Participate in internal initiatives focused on improving Computer Systems Validation processes and best practices.
Qualifications:
- Bachelor or Master’s degree in Lifesciences or Computer Sciences.
- A minimum of 5 years of experience in Computer Systems Validation is required for this role.
- Strong knowledge of GxP Requirements, GCP regulations, and 21 CFR part 11 requirements.
- Must have hands-on experience with the validation of IT infrastructure systems, including R, SAS, etc.
- Proven experience with GxP systems validation, such as ELN, LIMS, QMS, etc.
- Experience with Veeva Vault Systems is highly desirable.
Special Requirements
GxP Requirements, GCP regulations, 21 CFR part 11 requirements, validation of IT infrastructure systems, Veeva Vault Systems
Compensation & Location
Salary: $70,000 – $100,000 per year (Estimated)
Location: Hayward, CA
Recruiter / Company – Contact Information
Email: rsh.k809089@gmail.com
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