Controls Engineer, Level 3

Senior Automation, Instrumentation & Controls Engineer

Portsmouth NH

1st shift Mondy – Friday 8am – 5pm

Today, Lonza is a global leader in life sciences operating across five 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.

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.

Key Responsibilities

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 Distributed Control Systems (DCS)
- PLC-based control systems
- Process instrumentation and field devices
- I/O architectures and communication networks
- OPC/Kepware interfaces
- 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 (FS)
- Design Specifications (DS)
- Configuration Specifications
- Test Protocols
- 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
- Applicable GMP regulations and corporate standards

Collaboration & Mentorship

- Represent Controls Engineering in governance forums, Integrated Project Teams (IPTs), Joint Project Teams (JPTs), 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.

Required Qualifications

Education

- Bachelor's degree in Engineering, Automation Engineering, Electrical Engineering, Chemical Engineering, Computer Engineering, or related technical discipline.

Experience

- Significant experience supporting GMP manufacturing automation and process control systems within the biopharmaceutical, pharmaceutical, biotechnology, or regulated manufacturing industry.
- Demonstrated experience leading complex controls engineering projects and technology transfers.
- Strong experience with DeltaV, PLCs, process instrumentation, and industrial automation systems.
- Proven success leading technical investigations, root cause analysis activities, and complex troubleshooting efforts.
- Experience supporting commissioning, qualification, validation, and startup activities within regulated environments.

Technical Knowledge

- Expertise in automation system architecture, process control strategies, and manufacturing execution environments.
- Strong understanding of GMP regulations and computerized system compliance requirements.
- Experience with PI Historian, change management systems, and electronic quality management platforms.
- Knowledge of process instrumentation, networking, industrial communications, and batch control systems.
- Familiarity with risk assessment methodologies and lifecycle management principles.

Every Day, Lonza's Products and Services Have a Positive Impact on Millions of People.

For us, this is not only a privilege but also a great responsibility. We look for individuals who are driven by improving patient outcomes, committed to operational excellence, and eager to contribute to a culture of innovation, collaboration, and continuous improvement.

Come grow with us and make a meaningful difference.

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