CSV Engineer III at FUJIFILM Holdings America Corporation

The Computer System Validation (CSV) Engineer III, under general direction, will lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.

Reports to                Associate Director, Validation

Work Location         College Station, TX 

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies call Genki. 

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.

Job Description

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
• Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports).
• 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).
• 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.

Qualifications:

• Master’s Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
• Bachelor’s Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
• Associates Degree with 6+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
• Knowledge of DeltaV automation platform.
• 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.
• 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 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:

• Experience prolonged standing, some bending, stooping and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
• Working on ladders.
• Attendance is mandatory.

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (