FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Engineer for Manufacturing Automation and IT Systems. The position will deliver day to day operations support as well as execute his/her project work in line with stakeholder’s expectations. The automation group consists of 3 – 4 automation engineers supporting manufacturing, process development, and facilities/maintenance.
Reporting directly to the Sr. Automation Manager, the Senior Engineer is responsible for supporting the day-to-day operations as well as implementation of new technology and modifications to existing systems aimed at cost reduction, efficiency improvements, system sustainability, and quality/safety enhancement.
The automation group has direct ownership of the site automation systems including both ABB DCS (MOD300 and 800xA) and DeltaV DCS, BMS (JCI and Siemens), PLC (Allen Bradley and Siemens), and OSI-Pi data historian.
The Senior Engineer should be capable of working in the DELTA-V environment, but also be strong in IT infrastructure and systems. This engineer will run and manage the entire manufacturing site IT backbone that supports all manufacturing SCADA systems.
This Senior Engineer will also work with vendors and contractors to upgrade the network, servers and put in place new procedures to better manage the network, servers, Thin Clients and workstations running DELTA-V and other SCADA’s.
The Senior Engineer will also be the ADMIN for DELTA-V and all its components and provide support to other automation engineers in DELTA-V.
This Senior Engineer needs to feel comfortable working setting up systems on a network as well as working with hardware and troubleshooting server and workstation or communication issues.
Essential Duties and Responsibilities
- Interface and build collaborative partnerships with key site functions including Manufacturing, Technical Operations, Engineering, and Quality to deliver site goals and objectives
- Actively manage contractor activities to ensure work quality and safe practices to facilitation of contractor training
- Provide training or presentations on automation systems and tasks to all site personnel
- Maintain and support manufacturing automation LAN (Local Area Network) and VLANS.
- Maintain and support all manufacturing automation servers, switches, routers, workstations and thin-clients.
- Strong Server OS (operating Systems, MS-Win 2008, 2012, 2016) and VM (virtualization) knowledge.
- Maintained 100% customer satisfaction for all technical support calls.
- Provide hands-on detailed diagnostics/troubleshooting support for manufacturing, development, and utilities automated process control and monitoring systems
- Support the design and implementation of sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBU standards and cGMP regulatory requirements while following GAMP guidelines
- Support capital projects with an automation element from conception, design and initial specifications through completion and turnover.
- Develop/Revise User Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for new and existing control systems
- Develop and execute validation protocols in compliance with IQ/OQ/PQ requirements and the Site Master Validation Plan strategy
- Perform data back-ups of the DCS and BMS systems
- Develop, revise and abide by standard operating procedures and automation engineering documents.
- Lead, support, and perform investigations relating to complex manufacturing deviations and anomalies associated with automation systems and control system software in order to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence
- Other duties as assigned
- Demonstrated leadership, interpersonal, technical aptitude, and problem solving skills.
- Must be flexible and able to manage multiple priorities and projects
- Must be results driven and goal oriented with the ability to manage risks
- Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to upper management
- Ability to organize and present technical overviews to engineering staff, cross functional departments, and upper management
- Maintains effective relationships across functional units gaining their trust and respect
- Puts accomplishing the goals of the group ahead of accomplishing individual goals
- Openly shares knowledge/information needed to accomplish a task or solve a problem
- Exhibits professionalism and sets an example for others to follow
- Self-starter and detail oriented
- Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-technical personnel
- DeltaV generating code for Control Modules, Equipment Modules and batch-level programming from Phases up through Procedure level configuration
- DeltaV system configuration and commissioning of new controllers, cards and DSTs either individually or through bulk edits
- Generation of control and equipment module instances and new classes as needed
- Set-up of cross-system communication points between DeltaV and PLC systems
- Modification and creation of DeltaV graphics, dynamos and workstation specific configuration files
- Implementation of revisions to batch recipes requiring changes to formulas, procedures, unit procedures, operations and deferments.
- Working skis in OSI-PI.
- Basic knowledge of a variety of automation software applications, process control, SFC, Ladder Logic, and structured text programming languages
- Troubleshoot and repair hardware issues, like workstation motherboards, power supplies and peripherals.
- Provided Technical Support for the Windows/PC and teams
- Documented issues, bugs, and workarounds via SAS Notes and Defects.
- Software & Hardware troubleshooting: POST Errors, malware, routers, switches
- Software Management via Group Policy & SCCM services
- Manage print servers
- Proficient computer skills with experience using MS Office software
- Excellent documentation skills.
- Strong technical aptitude for problem solving and data driven decision making
- Good working knowledge of electrical systems, instrumentation and process controls
- Basic knowledge of Oracle and SQL Server databases
- Basic knowledge of IQ/OQ/PQ requirements in a regulated industry
- Basic knowledge of FDA regulation 21 CFR Part 11
Education and Experience
- Bachelor’s Degree in Engineering (Mechanical, Chemical, Electrical, Biochemical, Computer Science)
- 10+ years relevant experience in process automation, preferably in cGMP regulated industry
- Microsoft certified Engineer (desirable)
- Knowledge of Data Integrity on FDA regulated environments.
- Knowledge of compliance industry regulations (cGMP, GxP, 21 CFR Part 11, GAMP, SOX and ISO)
Certifications and Skills
PCS/DCS/SCADA (DeltaV, Foxboro, Provox) including S88 batch, Ladder Logic (Sy/Max, RSLogix, ControlLogix & SIMATIC), Relay Logic, OSISoft PI System, GE Proficy, Microstation, VBA, and VB.Net. Familiar with cGMP tasks/items such as: SOPs, MOC, incident reporting (IR), and PSUSRs. Experience with virtualization systems (ESXI/vSphere, Proxmox), Microsoft certified Engineer.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.