Operational Technology Systems Engineer
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 Bioscience has a new opportunity for an Operational Technology Systems Engineer in Walkersville, MD. This individual will support ongoing Lonza operations through systems administration, installation, upgrades and technical assistance as it relates to computerized systems and infrastructure for process automation, QC laboratory and other manufacturing operation systems. Provide a technical resource to operations customers to ensure that systems are designed and operating to meet production needs.
- Responsible for various support functions for computer systems, middleware, databases/Historian (OSI PI), and software applications that are utilized with manufacturing, QC, QA, and Operations.
- Provide OT infrastructure support (servers, networks, HMIs workstations, Virtual Machines, storage, and client devices) for Automation, Business Analytics, Quality Control, and any other information systems used to support Operations.
- Maintain system/data integrity and identify performance and security improvements
- Maintain site computerized system inventory
- Perform Data Integrity Risk Assessments (DIRA) and FMEA’s on new and existing systems.
- Complete computer system ID and assessments (CSIDA)
- Responsible for routine system application administration (i.e. set up new users. roles, groups, data set up, software configuration, etc.)
- Administer/manage for HMIs (DeltaV, Rockwell Automation, Siemens etc.), Wonderware, Emerson MES system (Syncade), Batch Record Systems (Moda ES) etc. backups and the recovery in the event of discontinuity of services
- Investigates and troubleshoots technical problems of increasing complexity with Historians, MES systems, SCADA/PLC, Alarm Management System, HMIs, Control Networks and related systems
- Support and Maintain access and backup of Recipe Management Systems, Batch Records and related electronic documents
- Develop, test and maintain disaster recovery procedures
- Administers appropriate change control, security, and backup/ recovery procedures to maintain validated and compliant status of system according to organizational and FDA guidelines
- Lead the planning and execution of projects involving computerized infrastructure change, upgrades and process improvements
- Contributes to design of new applications and solutions, prepare user requirement specifications (URS)
- Comply with 21 CFR Part 11 and Annex 11 regulations
- Perform investigations for quality deviations and implement corrective/preventive actions as necessary.
- Review/revise system SOP’s, Functional Specifications, and work instructions, as a result of CAPA, equipment/process changes, error prevention activities, etc.
- Perform other duties as assigned.
- Bachelor’s of Science or Engineering in Computer Science, Information Systems or Technology, or engineering discipline
- Working knowledge of Windows operating systems
- Proficient with Microsoft Office Suite with focus on Outlook, Word, Project and Excel
- Knowledge of computer software/hardware, operating systems, databases and applications.
- Ability to troubleshoot and resolve hardware and software issues.
- Experience in the following areas:
- plant network infrastructure including Ethernet IP/ DH485 and deterministic networks
- data historians for eg OSI PI, Factory Talk Historian and DeltaV continuous Historian
- process control systems (DCS, PLC/SCADA, MES, Wonderware, Asset Center etc.)
- laboratory computerized management systems (e.g. Labwatch, Recipe Management Systems and Electronic Batch Records)
- manufacturing systems that meet Operations' business requirements
- Proficiency with OSI PI and LIMS is preferred
- Experience with conducting risk assessments, periodic reviews, system backups, conducting end-of-life assessments
- Ability to think critically and logically, to analyze situations and develop solutions to problems in a timely manner.
- Strong project management skills
- Strong communication skills and able to work independently and in team environments
- Strong organization and prioritization of daily tasks and projects.
- Must be familiar with GAMP and 21CFR Part 11 requirements.
- Able to write complex procedures and reports.
- Able to communicate status, needs, forecasts, risks and timelines effectively to management.
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 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.