Senior Automation Engineer
Research Triangle Park, North Carolina
FUJIFILM Diosynth Biotechnologies is searching for a junior or senior Automation engineer to support Bioprocess operations at their NC site. The primary purpose of this position is to provide diagnostics/troubleshooting support for the manufacturing, development, and facilities process control and monitoring systems with some focus on implementing new process automation technology in Bioprocessing industry.
Under minimal supervision, the Automation Engineer is responsible for the day to day operations which include maintenance, troubleshooting, and technical support as well as supporting the design, procurement, installation and start-up of automated systems running Bioprocess equipment like Autoclaves, CIP, SIP, Fermenters, Bioreactors, Centrifuges…etc, in accordance with FDBU standards and cGMP regulatory requirements. As such, this position requires a strong knowledge of pharmaceutical process equipment automation. An exception to Biopharmaceutical background could be made if the candidate provides a strong background in ABB DCS (MOD 300 and 800xA) with at least 10 years of working field experience supporting such systems.
The Automation Engineer will support/own the site automation systems including but not limited to ABB DCS (MOD 300 and 800xA), BMS (JCI and Siemens), Emerson’s DeltaV DCS, PLC (Allen Bradley and Siemens), GE Healthcare Unicorn software, Xcellerex-Sartorius Single Use Equipment, OSI-Pi data historian, and electronic batch reports. The Automation Engineer will possess technical expertise for at least 1 of the core systems (ABB) allowing him/her to work independently within this system while being knowledgeable in other areas like DeltaV and Rockwell PLC’s.
This position will require participation in a weekly rotating after-hour process automation support function.
This position will directly report to the Automation Sr. Manager Engineering.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide hands-on detailed diagnostics/troubleshooting support to 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 following GAMP guidelines
- Manage small automation capital projects or provide automation support for capital projects with a dynamic workload based upon site priorities
- Update and develop User Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for new and existing equipment and control systems
- Generate and execute IOQs and PQs for new and revised processes and equipment
- 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
- 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
- Proficient computer skills
- Excellent documentation skills.
- Strong technical aptitude for problem solving and data driven decision making
- Must have working knowledge and demonstrated capabilities working with DCS implementation, PLCs, HMIs, data historians, industrial communication networks, and system integration in a cGMP industrial setting
- Demonstrated capability in programming and troubleshooting PLCs/HMIs for complex processes which involve the use of batch programming, data acquisition, and PID control
- Sound working knowledge of electrical systems, instrumentation and process controls
- Sound working knowledge of process control and equipment automation in biotech or pharmaceutical manufacturing facility
- Basic understanding of bioprocessing equipment design principles and sanitary equipment design requirements to include cGMP software quality system principles and data integrity regulations
- Basic understanding of theories/practices utilized by other disciplines outside primary area of expertise (e.g. validation, process engineering, quality, etc.)
- Demonstrated project management skills for small capital projects ensuring project delivery to customer expectations, schedule, and budget
- Proficiency with ABB DCS 800xA and Advant MOD 300 batch processing systems
- Working knowledge of a variety of automation software applications, process control, SFC, Ladder Logic, and structured text programming languages
- Working knowledge of Oracle and SQL Server databases
- Working knowledge of OSI Pi Data Historian
- Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management
- Ability to organize and present technical and project management overviews to engineering staff, cross functional departments, and management without assistance
- Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
- 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 manage commitments for self and the team while displaying an eagerness to learn and continuously improve
- Excellent presentation skills with the ability to clearly articulate sound reasoning and data when recommending courses of action
- Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-automation personnel
- B.S. Degree in Chemical, Electrical, Mechanical, or Computer Engineering with 10+ years’ experience of relevant process automation or 15+ years’ equivalent process automation work experience. Must include 5+ years’ process automation experience in the bio-pharmaceutical industry including both upstream and purification process operations, clean process utilities, and plant utilities, but will exempt the Pharma requirement is the engineer possesses strong ABB DCS background.
- M.S. Degree in Chemical, Electrical, Mechanical, or Computer Engineering with 5+ years’ experience of relevant process automation. Must include 3+ years’ process automation experience in the bio-pharmaceutical industry including both upstream and purification process operations, clean process utilities, and plant utilities, but will exempt the Pharma requirement is the engineer possesses strong ABB DCS background.
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.