The Position

This position is a leader for all technical, quality and project issues within the Automation Engineering team at our manufacturing facility. This person is responsible to provide support, training, mentoring and guidance for less experienced engineers. This person is expected to be knowledgeable of all aspects of Automation/Process Controls Engineering. This person is responsible for the development of short- and long-term goals and vision for Automation Systems at our GMP bioproduction facility. This person is responsible for maintaining all systems in compliance with all relevant regulations. This position will work closely with stakeholders within a matrixed environment that include local departments across our site, and specialized service centers within the broader Novo network domestically and internationally. We are seeking an individual who can combine deep technical knowledge of process engineering/automation, with a passion for leading a team and developing your team. Prior experience in a GMP Manufacturing environment is preferred.

This is an onsite based role Monday-Friday at our West Lebanon, NH 24/7 bioproduction facility. This role is eligible for relocation assistance in line with Novo Nordisk policies/criteria for relocation eligibility.

Relationships

Reports to: Director, Project Office & Supply Chain

Number of reports: Approx. 8 FTE's, and oversight of contractors/vendors

Essential Functions

• Responsible for the hiring and training of new members of the Automation Engineering team
• Develops, reviews and approves Automation SOPs, Work Instructions and Forms as Function Area Approver / Signatory
• Reviews and approves Automation Engineering CAPAs, Deviations, and Investigations as Function Area Manager
• Full responsibility for the design, implementation, start-up and troubleshooting of automation and plant floor control systems
• Responsible for the design and / or selection of instrumentation, control devices, control panels and control / electrical power systems throughout the facility
• Serves as the lead interface between Automation, Process & Facilities engineering, facilities, process teams, information systems, quality assurance, validation and operations for projects related to Automation & Control Systems
• Takes the lead with the troubleshooting, testing, validation, deployment and on-going maintenance of Automation Systems
• Normally receives minimal instructions on routine work and general instructions on new assignments
• Provides support to manufacturing and facilities areas including the following activities:
  • Support for resolution of deviations, investigations, and other quality issues
  • Tracking and evaluating control system trends or issues in collaboration with quality, engineering and manufacturing
• Leads the design, procurement, construction, installation, engineering start-up, documentation and validation activities of new and modified systems
• Participates in the development and implementation of procedural or automation improvements to support Plant Objectives
• Point person for complex process improvement and start-up activities involving automation and plant floor related business systems
• Initiates project(s), tracks spending / budgets, creates scope of work, develops risk assessments, justification, cost estimates, implements purchase requisitions, funding requests, and manages contracts
• Provides direction and coordination to the automation engineers, which includes mentoring, training, project oversight, support and advice on all aspects of plant Automation
• Provides support for troubleshooting for the more complicated issues found in the manufacturing environment
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

Development of People

Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business and that interim reviews are held so that their work is focused on those priorities and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures and Novo Nordisk Way.

Qualifications

• Education and Certifications:
  • Bachelor's degree in engineering, Automation, or Computer Science or equivalent experience in life sciences or engineering; master's degree in engineering, Automation, or Computer Science preferred
• Work Experience:
  • At least 10 years' experience in Plant Automation / Controls Engineering required with relevant bachelor's degree or at least 6 years with relevant master's degree
  • 5+ years of experience at a medium to large scale medical device, pharmaceutical or biotechnology process firm in an automation role is required
  • Experience and skills to lead and manage multiple complex tasks or projects
• Knowledge, Skills, and Abilities:
  • Ability to manage a team of knowledgeable professionals in a regulated biopharmaceutical manufacturing environment
  • Provide leadership for site Process and Building Control Systems
  • Strong knowledge and experience with the following is required
  • Instrumentation & Control Device operation and troubleshooting
  • Programmable Logic Controllers
  • Supervisory Control & Data Acquisition Systems (SCADA)
  • Variable Speed Drives
  • Electrical systems such as 120 VAC, 24 VDC, 480 VAC
  • GAMP guidelines
  • NFPA codes related to Automation & Electrical work
  • Strong knowledge of Microsoft Windows Operating Systems and Networking systems (Ethernet) is required
  • Strong knowledge of FDA and EMEA Regulatory requirements is required (Part 11/Annex 11)
  • A successful history of managing teams and/or projects
  • Knowledge of AutoCAD (ability to view, make minor changes) is desired
  • Demonstrated experience working in a team-oriented environment is required
  • Strong knowledge of the Microsoft Office Suite (Word, Excel, Visio, Project, & PowerPoint) is required
  • Excellent oral and written communication skills is required

Physical Requirements

0-10% overnight travel required. The ability to stoop, kneel, crouch, reach, stand, and walk. The ability to grasp and finger. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. Lifting up to 15kg/33lbs of force occasionally. Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including noise, inside and outside conditions, working in narrow aisles, and temperature changes; atmospheric conditions including: odors, fumes, and dust.