- Optimize system configurations to maximize performance and ensure availability
- Participate in planning and implementation of system changes and upgrades
- Perform periodic maintenance and systems review, including security roles, performance, and data integrity
- Maintain close collaboration with Quality departments, including business system owners
- Develop and maintain system documentation
- Support internal and third party inspections and audits (FDA, EMA, Clients, etc.)
- Troubleshoot and resolve questions/problems with assigned applications
- Resolves and/or coordinates the resolution of technical issues with assigned applications
- Create documentation for assigned applications and internal processes (SOPs)
- All other duties as assigned
Required Skills & Abilities:
- Strong technical documentation skills
- Broad knowledge of laboratory and quality processes.
- IT Administration experience with any/all of the following Quality Systems:
- LabWare LIMS, including experience with the horizontal integration of LabWare to other
- enterprise systems and integration of pharmaceutical analyzers
- Waters Empower
- Moda Environmental monitoring
- Electronic Lab Notebook systems
- Knowledge / experience with Citrix as necessary to support LabWare and Empower
- Database administration experience preferred
- Proficiency writing SQL Queries
- Proficiency creating custom reports using Crystal Reports or similar documentation tools
- Knowledge of the Software Development Life Cycle (SDLC) for regulated life sciences industries.
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 sitting, standing, 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.
- Regularly lift up to 20 pounds and lift up to 50 pounds on occasion.
- Attendance is required.
- BS Degree in Information Technology, Chemistry, or Engineering with a knowledge laboratory or
quality control/assurance operations.
- 3+ years of work experience in a cGMP/highly regulated environment, including understanding of
Change Control, Computer Systems Validation, 21CFR/Part 11 compliance
Salary: Starting salary will be commensurate with education and experience.
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 e-mail FDBTHR@fujifilm.com or call 979-431-3528.