Computer engineer Jobs in College Station, TX

Job Description

Job Description

Salary :

The Computer System Validation (CSV) Senior Engineer, under general direction, will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems.

Essential Functions :

• Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation / Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
• Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
• Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
• Must be able to create, review, and update SOPs, forms, templates, documentation, and files.
• Supports regulatory and client audits as CSV subject matter expert.
• Actively works to establish strong relationships within the group and with other department managers to improve harmonization and effectiveness.
• Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation, and industry codes.
• Perform other duties as assigned.

Required Skills & Abilities :

Working Conditions & Physical Requirements :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to :

Qualifications :

Preferred Qualifications :

Knowledge of DeltaV automation platform