About the Department     

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position

This individual is responsible for architecting and coordinating the design, installation, commissioning, startup and validation of all assigned new capital improvement projects. Primary the system administrator and quality system interface for Siemens Building Management System (BMS) and Environmental Monitoring System (EMS).

Relationships

Reports to: Manager of Automation Engineering

Essential Functions

• Lead, plan, organize and coordinate the execution of projects from design through construction, commissioning, start-up and validation, ensuring that projects run on schedule, are cost effective and meet organizational objectives
• Communicate and interact with contractors and ensure that work is performed safely and meets contractual specifications, scheduling and financial requirements. Communicate status of projects to applicable project team
• Project Installation Support: Sub-contractor supervision, BMS system start-up, commissioning, and training
• Project Startup: Validate network functionality, provide programming support, and certify the operation of the BMS system with appropriate documentation
• Ensure that assigned projects conform to good engineering practices and that all applicable commissioning, validation, GLP and GMP requirements are met or exceeded in accordance with project objectives
• Act as system administrator for the BMS system and act as subject matter expert regarding technical issues
• Support and develop and coordinate training for community of BMS users
• Develop and implement project(s) under the support of Sr. Engineer or external consultants as appropriate to maintain the BMS system throughout the component and software lifecycle
• Provide input during regulatory inspections of BMS and relevant projects as needed
• Work with the project manager to coordinate the activities and needs of the installation team
• Work with other project team members during the design phase of the project to provide feedback relative to the local site
• Participate in on-call rotations, including weekends and non-business hours, to provide support for critical BMS, EMS systems
• 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
• Other duties as assigned

Physical Requirements

Local and International Travel: 0-10%.

Qualifications

• Education and Certifications:
  • Associate’s degree in engineering or related discipline required
  • Bachelor’s degree in engineering or related discipline preferred
• Work Experience:
  • Associate’s degree with seven (7) years’ experience in Automation, Building Management Systems, Design and construction required
  • Bachelor’s Degree with five (5) years’ experience in Automation, Building Management Systems, Design and construction preferred
  • Pharmaceutical, Biotechnology or other regulatory industries experience preferred
  • Three (3) years of experience with Siemens Apogee software and system administration preferred

• Knowledge, Skills, and Abilities:
  • Instrumentation & Control Device operation and troubleshooting
  • PPCL Programming experience is preferred
  • Understanding Supervisory Control & Data Acquisition Systems (SCADA)
  • Electrical systems such as 120 VAC, 24 VDC, 480 VAC
  • GAMP guidelines
  • Part 11 and Annex 11 requirements
  • NFPA codes related to Automation & Electrical work
  • Ability to develop new systems and reverse engineer existing systems
  • Lead external contractors for project execution
  • Manage a project from inception to production and long-term support
  • Execute design reviews and risk analysis
  • Microsoft Office Suite (Word, Excel, Visio, Project, & PowerPoint)
  • Excellent oral and written communication skills
  • Strong knowledge of Microsoft Windows Operating Systems and Networking systems
  • (Ethernet)
  • 10 plus years of experience at a medium to large scale medical device, Pharmaceutical or biotechnology process firm in an automation role is desired
  • Demonstrated experience working in a team-oriented environment
  • Experience and skills to lead and manage multiple complex tasks or projects
  • Strong knowledge and experience implementing FDA and EMEA Regulatory automation requirements
  • Knowledge of AutoCAD (ability to view, make minor changes) desired
  • Understanding of Network Architecture, VM Machines and IT Equipment

About Novo Nordisk, Inc.

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 66,000 people in 80 countries and markets its products in around 170 countries.

Connections working at Novo Nordisk, Inc.