CSV Validation Engineer

Zifo•Hayward, CA

About The Position

Responsible for validation strategy and planning, executing and qualification of computer systems and/or infrastructure components in accordance with applicable policies procedures and regulatory 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 CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Requirements

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

Responsibilities

validation strategy and planning, executing and qualification of computer systems and/or infrastructure components in accordance with applicable policies procedures and regulatory 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