FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Automation Manager (internally known as a Senior Engineering Manager). The successful candidate is recognized as the leader of the Automation and Lab Engineering groups of FDBU. The position will ensure deliverables for the respective groups are well established and in line with their stakeholders expectations. The automation group consists of 3 – 4 automation engineers supporting manufacturing, process development, and facilities/maintenance. The lab engineering group consists of 3 exempt employees responsible for troubleshooting, maintenance, and qualification of QC and PD lab analytical equipment.
Reporting directly to the Associate Director of Engineering, the Senior Automation Manager oversees the day-to-day activities 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 Senior Automation Manager will directly support or assign responsibility for support of capital projects with an automation element in accordance with FDBU and GAMP standards. As such, this position requires solid working knowledge of process equipment automation and the associated automation systems.
The automation group has direct ownership of the site automation systems including but not limited to ABB DCS (MOD300 and 800xA), DeltaV DCS, BMS (JCI and Siemens), PLC (Allen Bradley and Siemens), and OSI-Pi data historian. This position will possess technical knowledge for these core systems.
This position will be responsible for ensuring automation engineering support via a rotating 24/7 on-call schedule.
Essential Duties and Responsibilities
- Responsible for team of automation and lab engineers in support of site and departmental goals.
- Develop and manage team member’s performance and capabilities while providing formal and informal feedback to direct reports
- Assures team activities are carried out in a manner of compliance with FDBU standards and cGMP regulatory requirements
- Coaches team members in a learning culture with the goal of achieving employee empowerment and ownership
- Establishes team objectives and ensures alignment with site and departmental goals
- 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
- Provide hands-on detailed diagnostics/troubleshooting support for manufacturing, development, and utilities automated process control and monitoring systems
- Assess equipment and control systems to design and implement 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
- Independently manage or ensure support required for capital projects with an automation element from conception, design and initial specifications through completion and turnover. This includes developing detailed and accurate project schedules while collaborating with internal cross functional teams, end users, and third party contacts to maintain project deliverables
- 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
- Develop, mentor, and train team members on control systems functionality, troubleshooting, and diagnostic techniques to enhance overall capability of the group
- 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
- Provide process automation subject matter expertise for regulatory inspections and interact with auditors as required
- Other duties as assigned
- Demonstrated leadership, interpersonal, technical aptitude, and problem solving skills. Strong team building skills, including ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict.
- Must be flexible and able to manage multiple priorities and projects
- Must be results driven and goal oriented with the ability to manage risks
- Hands-on active management style while maintaining awareness of team activities
- 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 manage commitments for self and the team while displaying an eagerness to learn and continuously improve
- Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-technical personnel
- Must have working knowledge and demonstrate a high level of proficiency with DCS implementation, PLCs, HMIs, data historians, industrial communication networks, and system integration in a cGMP industrial setting
- Programming and troubleshooting PLCs/HMIs for complex processes which involve the use of batch programming, data acquisition, and PID control
- Working knowledge of process control and equipment automation
- Display a solid 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 ensuring project delivery to customer expectations, schedule, and budget
- Working knowledge of DCS batch processing systems following ISA88 standard
- Working knowledge of Oracle and SQL Server databases
- Working knowledge of OSI Pi Data Historian
Education and Experience
- Bachelor’s Degree in Engineering (Mechanical, Chemical, Electrical, Biochemical, Computer)
- 10+ years relevant experience in process automation, preferably in cGMP regulated industry
- 5+ years’ experience managing technical/engineering staff
- Certified Automation Professional (CAP) a plus
- Project Management Professional (PMP) a plus
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.