 |
|
Computer Systems Validation Engineer
Responsible for the computer validation activities associated with the assigned validation projects. This individual will work closely with cross-functional organizations in planning and executing the computer validation activities in accordance with departmental guidelines, policies, and procedures. Coordinate resources from internal organizations to develop and communicate project timelines and status.
Responsibilities include, but not limited to, development of Validation project plan, vendor evaluation documentation, IQ/OQ/PQ protocols, final reports and other required documentation. Coordinate and interact with all affected personnel, including consultants, in the execution of validation protocols and gathering of test data. Ensure all protocol executions are documented and recorded in accordance with company SOPs. Analyze data to determine if it meets protocol acceptance criteria and document deviations as necessary. Ensure all final reports are documented and approved through proper channels.
Minimum of 2 years directly related experience in computer validation, preferably in a pharmaceutical environment; or an equivalent combination of education and experience. Direct experience with validating an ERP system, preferably SAP. Familiar with FDA regulations relating to computer systems validation, including CFR Part 211 and CFR Part 11 (Electronic Records and Signatures). Familiar with Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and related federal, state and local laws, codes, regulations and regulatory requirements.
Bachelor’s Degree in Engineering, Computer Science, or related field
|
| Additional Information |
Position Type:
Employee
Ref Code: CSV Cal |
|
|
|
|
