Controls Engineer, Level 3

The Role

Lonza is seeking a highly experienced Senior Automation, Instrumentation & Controls Engineer to provide technical leadership for complex GMP automation, instrumentation, and process control systems supporting commercial biopharmaceutical manufacturing operations. This role serves as a key Controls Subject Matter Expert (SME), leading technical investigations, system enhancements, capital projects, and technology transfers while ensuring compliance, reliability, and operational excellence across site manufacturing systems.

The successful candidate will establish technical direction for complex automation initiatives, collaborate across Manufacturing, Quality, Engineering, Validation, and MSAT functions, and play a critical role in enhancing site capabilities through system reliability improvements, compliant engineering practices, and mentorship of developing engineers.

Technical Leadership & System Ownership

• Provide senior technical leadership and oversight for GMP automation, instrumentation, and control systems supporting manufacturing operations.
• Lead complex technical support, reliability improvement, and lifecycle management activities across assigned manufacturing processes and controls platforms.
• Establish technical approaches and engineering strategies for ambiguous or complex assignments requiring independent judgment and risk-based decision making.
• Serve as the primary Controls SME for Manufacturing, MSAT, Engineering, Quality, and project teams.

Automation & Controls Engineering

• Lead the design, implementation, testing, and deployment of complex automation changes involving Emerson DeltaV DCS, PLC-based control systems, process instrumentation and field devices, I/O architectures and communication networks, OPC/Kepware interfaces, and batch reporting and data collection systems.
• Own complex control system modifications and provide technical review and approval of engineering documentation, including P&ID updates and work orders.
• Develop and approve automation strategies that balance manufacturing needs, system reliability, lifecycle sustainability, and regulatory compliance.

Projects & Technology Transfers

• Lead Controls and Automation scope for capital projects, process expansions, and technology transfer activities.
• Develop project estimates, schedules, resource plans, risk assessments, and contractor management strategies.
• Coordinate cross-functional activities to ensure successful implementation and startup of automation-related projects.
• Drive stakeholder alignment while managing competing project priorities.

Troubleshooting & Investigations

• Lead high-complexity troubleshooting efforts across manufacturing systems and control platforms.
• Utilize historian data (OSIsoft PI), code reviews, configuration assessments, root cause analysis methodologies, and cross-functional investigations to identify and resolve system issues.
• Assess process and automation risks and recommend corrective and preventive actions to prevent recurrence.
• Support manufacturing operations during critical events and participate in site on-call support activities.

Compliance & Validation

• Author, review, and approve Functional Specifications, Design Specifications, Configuration Specifications, Test Protocols, and Validation Documentation.
• Define testing strategies and lead FAT, SAT, commissioning, startup, and validation-support activities.
• Own and approve quality records including deviations, CAPAs, investigations, and change controls.
• Ensure documentation is completed within Kneat, TrackWise, DMS, and Veeva systems in accordance with site procedures and regulatory requirements.
• Ensure compliance with GAMP 5, ISA-88, 21 CFR Part 11, EU Annex 11, and applicable GMP regulations and corporate standards.

Collaboration & Mentorship

• Represent Controls Engineering in governance forums, Integrated Project Teams, Joint Project Teams, customer discussions, client audits, and regulatory inspections.
• Provide technical mentoring and coaching to automation and controls engineers.
• Lead technical reviews, establish engineering standards, and share lessons learned across the organization.
• Provide direction and oversight to contractors, integrators, and project resources.