FUJIFILM

  • Senior Automation Manager

    Job Locations US-NC-Morrisville
    Posted Date 2 months ago(6/8/2018 9:45 AM)
    Requisition ID
    2018-2605
    Category
    Engineering
    Company (Portal Searching)
    FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
  • Overview

    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 both as the technical subject matter expert and leader of the Automation Engineering group of FDBU. The position will ensure deliverables for the automation group are well established and in line with their stakeholders expectations. The automation group consists of 3 – 4 automation engineers along with computer systems validation engineer supporting manufacturing, process development, and facilities/maintenance. In addition, this position may also have oversight of the lab engineering group consisting 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 of the automation group as well as implementation of new technology and modifications to existing systems aimed at cost reduction, efficiency improvements, system sustainability, and quality/safety enhancement. This position is expected to carry an appropriate workload for automation deliverables in support of the group’s responsibilities as well as having management responsibility.

     

    The Senior Automation Manager will directly support or ensure support of capital projects with a process automation element in accordance with FDBU standards and cGMP regulatory requirements. As such, this position requires an in-depth knowledge of pharmaceutical 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), GE Healthcare Unicorn software, Xcellerex and Sartorius Single Use Equipment, OSI-Pi data historian, and electronic batch reports. As such, this position will possess technical expertise for all of the core systems (DCS, BMS, and PLC) as well as a sound working knowledge of all the remaining site automation systems allowing him/her to work independently within any system.

     

    This position will be required to back-fill for automation engineers participating in a rotating 24/7 automation support function.

     

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    #CB

    External US

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

     

    Management

    • Responsible for team of automation and computer system validation engineers in support of site and departmental goals. May also have responsibility of lab engineering group
    • 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

     

     

    Performance

      • Provide hands-on detailed diagnostics/troubleshooting support to 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 provide 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 concurrently 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
      • Develop, mentor, and train team members on control systems functionality, troubleshooting, and diagnostic techniques to enhance overall capability of the group
      • Ensure 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
      • Provide process automation subject matter expertise for regulatory inspections and interact with auditors as required
    • Other duties as assigned

     

     

    REQUIREMENTS:

    Management Qualifications:

    • 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

     

    Technical Qualifications:

    • Must have expert 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
    • Demonstrated excellence in 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 in biotech or pharmaceutical manufacturing facility
    • Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise (e.g. validation, process engineering, quality, etc.)
    • Solid understanding of relevant pharmaceutical PAT initiatives and the impact on regulatory guidelines
    • Demonstrated project management skills for ensuring project delivery to customer expectations, schedule, and budget
    • Working knowledge of ABB DCS 800xA and Advant MOD 300 batch processing systems following ISA88 standard
    • Working knowledge of DeltaV DCS batch processing system following ISA88 standard
    • 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

     

    Education/Experience:

    • B.S. Degree in Chemical, Electrical, Mechanical, or Computer Engineering with 15+ years’ experience of relevant process automation with 10+ years’ management experience. Relevant process automation must include 10+ years’ in cGMP environment.
    • M.S. Degree in Chemical, Electrical, Mechanical, or Computer Engineering with 10+ years’ experience of relevant process automation with 7+ years’ management experience. Relevant process automation must include 7+ years’ in cGMP environment.

     

    Certifications (Plus):

    • Certified Automation Professional(CAP)                                      
    • Licensed Control Systems Engineer(CSE)
    • Project Management Professional (PMP)
    • Lean / Six Sigma (Green / Black Belt)

     

    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.

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