- Provide support on a daily basis to process control system, building management systems and data historian systems.
- Perform system software updates, security updates and upgrades to newer version.
- Support and enforce the data integrity program.
- Support and maintenance of computerized systems.
- OSI Soft PI Historian and reporting system configuration and maintenance.
- Maintain Functional Specifications, Database Design Specifications and Hardware Design Specifications for automation systems.
- Develop and maintain standard operating procedures and trainings for automation systems.
- Create, support and maintain customer data sharing programs that includes but not limited to secure customer web portals.
- Assist in the development and implementation roadmap for the deployment of automation technologies.
- Execution of engineering test plans, factory acceptance test and site acceptance test.
- Assist in the development of software test specification, user requirements and functional specifications.
- Maintenance of automation related systems and configuration backup codes.
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation and industry codes.
- Knowledge of cGMP practices utilized in bulk drug, gene therapy, final formulation filling and vaccine manufacturing environment.
- Support computer system validation to ensure that appropriate regulations (e.g. 21 CFR Part 11 and cGMP) are addressed in a development phase and implementation level.
- Interfaces with IT to ensure GMP compliant integration with corporate IT infrastructure.
- Performs other duties as assigned.
Required Skills & Abilities:
- Desired experience with process control, building management, data historian, remote notification and manufacturing enterprise systems.
- Understand automation protocols like: HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC, OPC UA and Modbus TCP/IP.
- Assist in training of automation systems.
- Reliable, self-motivated individual with positive attitude; team-oriented with the ability to work with staff covering a variety of roles.
- Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities.
- Strong written, verbal and interpersonal communications skills.
- Must be able to work effectively and efficiently with minimal supervision in a schedule-driven, ever-changing work environment.
- Working knowledge of MS Office products (Word, Excel, Outlook, and Power Point).
- 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 sitting, standing, bending, stooping, climbing 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.
- Be exposed to noisy environments.
- Travel time up to 10%.
- Support company manufacturing activities 24/7.
- Attendance is mandatory
- Bachelor Degree preferably in Electrical, Mechanical, Chemical Engineering with one (1) year experience.
- Experience with critical and non-critical utilities, biotechnology equipment and complex pharmaceutical systems are a plus.
- At least 3 years of relevant automation engineering experience in the biotechnology /pharmaceutical industry.
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.