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Summary: 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.
- 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).
- Must be able to create, review, and update SOPs, forms, templates, documentation and files.
- 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 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.
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:
- 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.
- Bachelors in Science or Engineering
- Minimum of 3-5 years' experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products. Must have a minimum of three (3) years direct CSV validation experience.
- cGMP experience
- Knowledge of DeltaV automation platform
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law.
If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3528.