Operational Technology (OT) Systems Lead

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Pharma & Biotech is designing and building new, state of the art, highly integrated manufacturing facilities to produce life changing drug substances and products for the industry. These facilities are leveraging cutting edge technologies and advanced automation solutions to increase reliability and create greater insight to the process. The Strategic Growth Investments & Engineering (SGIE) team in Portsmouth is looking for a highly motivated and technical individual to lead the OT aspects of the projects.

The OT Project Lead is responsible for providing technical leadership and direct support in the execution and delivery of Operation Technology (OT) Computerized Systems for Process Automation, Manufacturing Execution and Data Historian Systems for large Capital projects within Lonza USA, including adherence to schedule and budgets, engineering design of new facilities (Basis of Design, Conceptual, and Detailed Design), and collaboration with/leadership of cross functional teams consisting of Internal Lonza customers such as SGIE project team members and Manufacturing, MSAT, and Quality Assurance to properly identify and ensure execution of design requirements. 

Key Accountabilities:

  • Responsible for providing technical leadership and direct support in the execution and delivery of the OT elements of large Capital projects within Lonza.
  • Design, identify, source, build, install, program, configure, commission and validate solutions
  • Design, specify, build, commission and validate the hardware infrastructure, network and core configuration
  • Gather requirements from key stakeholders and generate URS/FRS documentation, enforce and oversee qualification of OT systems to perform to those and current local and global Lonza OT security and infrastructure requirements.
  • General management and oversight to the OT systems and network documentation effort as well as assist with development of project schedule and then assure that system and network development, hardware purchase and install, and validation efforts adhere to plan.
  • Assist with Computer Systems Validation (CSV) activities: Validation Plan, Risk Assessment, Protocols, Test Protocols, Change Requests etc.
  • Understand and comply with 21 CFR Part 11, IQ7 and equivalent regulations
  • Project execution activities, including management of external engineering contractors and software/hardware vendors, coordinate and manage project activities
  • Protocol management and execution of validation activities
  • Provide routine project management updates in accordance with Lonza procedures

Key Requirements:

  • Bachelor’s Degree, preferably in science or engineering. Master’s Degree in similar field preferred. Automation Professional Certification desired.
  • Significant experience in automation and controls, with experience in EI&C (Electrical Instrumentation and Controls and MES (Manufacturing Execution Systems). Experience with DeltaV and Syncade highly desired.  
  • Significant experience with design and operation of Biopharmaceutical facilities, both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories).
  • Experience with control systems (PLC, DCS, Loop controllers) and networking systems
  • Working experience in project management and coordination associated with the execution of capital projects in an industrial environment
  • Experience with design and operation of large scale industrial continuous historians, preferably OSISoft PI.
  • Experience with MES integration with Enterprise Resource Planning (ERP) systems, preferably SAP
  • Experience with design of PCS, MES and associated Network Architecture
  • Experience with virtual machines, preferably VMware 
  • Team player with exceptional customer service skills. Requires strong attention to detail and analytical skills as well as problem analysis and resolution.
  • Ability to quickly adjust to a dynamic and fast paced environment

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if it is not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R28466