OT Engineer
Lonza
Summary
The OT Systems Engineer supports the design, implementation, and maintenance of Operational Technology (OT) systems at a regulated pharmaceutical oral solid dose (OSD) manufacturing site. This includes PLCs, HMIs, SCADA, BAS/BMS, data historians, LIMS, LMS, and automation interfaces across manufacturing, packaging, utilities, and laboratories.
Job description
This role ensures system reliability, cybersecurity, and GMP compliance through robust design, troubleshooting, user administration, and backup/recovery strategies. The engineer also supports Computer System Validation (CSV) activities in alignment with 21 CFR Part 11 and GAMP 5, maintaining validated backup libraries to ensure business continuity and data integrity.
Key Responsibilities
- Manage OT systems (PLCs, HMIs, SCADA, BAS/BMS, LIMS/LMS), ensuring compliance with GAMP and 21 CFR Part 11, and maintain architecture, configuration, and asset documentation.
- Maintain validated backups and perform restoration testing for all OT platforms to ensure disaster recovery readiness and compliance.
- Lead OT scope in equipment installations and upgrades, supporting FAT/SAT, commissioning, and validation in collaboration with Engineering and IT.
- Integrate lab instruments with OT infrastructure and troubleshoot automated lab workflows, maintaining documentation and backups.
- Provide advanced troubleshooting for automation faults and network issues, working with Engineering, QC, Maintenance, and IT to resolve problems.
- Implement OT cybersecurity controls, manage user access and patching, and support audits with validation and compliance documentation.
- Author SOPs and validation documents, support cross-functional initiatives, and drive automation optimization and digital transformation efforts.
Key Qualifications
- Bachelors Degree
- 5 years of relevant experience
- Pharma/GMP Experience is preferred
Requirements
- Bachelors Degree
- 5 years of relevant experience
- Pharma/GMP Experience is preferred
Company overview
Lonza is a pioneering global Contract Development and Manufacturing Organization (CDMO) and a world leader in pharmaceutical manufacturing services. Founded in 1897 in Switzerland, the company has evolved into the first and original CDMO, now operating as one of the largest Western CDMO networks with approximately 19,000 employees across more than 30 sites spanning five continents. Lonza specializes in transforming therapeutic discoveries into life-saving and life-enhancing treatments for patients worldwide. The company's comprehensive services span from early development to drug substance and drug product manufacturing, covering established and emerging technologies including mammalian biologics, small molecules, highly potent APIs, bioconjugates, mRNA, microbial products, and cell and gene therapies. With a focus on cutting-edge science, smart technology, and lean manufacturing, Lonza serves a diverse customer base ranging from emerging biotechs to global pharmaceutical companies, delivering integrated solutions throughout the entire treatment lifecycle.