- Support validation as the Subject Matter Expert to ensure that appropriate regulations (e.g. 21 CFR Part 11 and cGMP) are addressed in validation in a development phase and level.
- Interface with IT to ensure GMP compliant integration with Corporate IT infrastructure.
- Prepare, assist, and participate in system, specification development, and design.
- Provide support on a daily basis on Building Management Systems and Process Control Systems.
- Coding, programming, and configuration for continuous and batch controls.
- Responsible for DeltaV Batch recipe configuration, phases, EMs, CMs.
- Develop procedures to transfer technologies, recipes, parameters from process development to commercial manufacturing.
- Responsible for the DeltaV Virtualization.
- Responsible for the OSI Soft PI Historian configuration and maintenance.
- Maintain Functional Specifications, Database Design Specifications and Hardware Design Specifications for automation systems.
- Develop and maintain Automation Standard Operating Procedures and training for Automation Systems.
- Perform Engineering Test Plans for Automation.
- Support, configuration and maintain automation reporting systems like Infobatch.
- Execute Software Test Specification.
- Maintain backups of automation code.
- Provide engineering and technical review of new equipment purchases, including Request for Quote Bid Packages, design review, FAT and SAT.
- Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations and industry codes.
- Responsible for ensuring compliance with cGMP practices utilized in bulk drug and vaccine manufacturing environment.
- Performs other duties as assigned.
Required Skills & Abilities:
- Knowledge in Manufacturing Enterprise System including Weight and Dispense and EBR.
- Experience with Process Control System, SCADA design, implementation and operation of systems.
- Develop new code for continuous control and batch control.
- BMS, SCADA and DCS design, commissioning and validation in GMP facility.
- Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA.
- Computer knowledge of 21 CFR Part 11.
- Understand automation protocols like: HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC and Modbus TCP/IP.
- Experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, APOGEE, etc.
- 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 and a strong attention to detail. Must be able to develop, draft and correct preventative maintenance procedures for technical equipment.
- Must be able to work effectively and efficiently with minimal supervision in a schedule-driven, 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.
- Support company manufacturing activities 24/7.
- Attendance is mandatory
- Bachelor’s Degree preferably in Chemical, Electrical, Mechanical Engineering or closely related field with five (5) years of relevant automation engineering experience preferably in the biotechnology /pharmaceutical industry; OR
- Associates Degree preferably in Chemical, Electrical, Mechanical Engineering or closely related field with eight (8) years of relevant automation engineering experience preferably in the biotechnology /pharmaceutical industry
- Experience with critical utility and non-GMP utility systems a plus.
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.