Senior CSV Engineer

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki. 

External US

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

 

The Senior Computerized Systems Validation 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.

 

Reports to                Associate Director, Validation

Work Location         College Station, TX 

 

Primary Responsibilities:

• 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.
• Perform other duties as assigned.

Qualifications:

• Master of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 3+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
• Bachelor of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 5+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
• Associate of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 7+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
• Knowledge of DeltaV automation platform preferred.
• Working knowledge of engineering principles.
• Working knowledge and expertise in computerized systems validation.
• Computer System Validation experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred.
• Thorough knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations.
• Excellent written and oral communication skills.
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
• Ability to work with minimal supervision.
• Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to su