Senior Automation Engineer, GMP Vaccine Manufacturing

Emergent Biosolutions; United States; On-site; USD 150,000 - 176,000; Full time

Job summary

Emergent Biosolutions in Canton, MA is recruiting a Senior Automation Engineer to own site-level automation, control systems, and lifecycle management for manufacturing facilities.

You will lead GMP-compliant automation strategies, support regulatory inspections, and drive continuous improvement across utilities, facilities, and manufacturing operations. This role requires hands-on PLC/SCADA expertise and a collaborative mindset to mentor engineers and coordinate with cross-functional teams.

Qualifications

• Bachelor's degree in Electrical, Chemical, Mechanical, Biochemical Engineering; advanced degree preferred.
• Minimum of 8 years of progressive automation engineering experience within GMP-regulated environments; DS/vaccine experience preferred.
• Demonstrated expertise in GMP automation, CSV, and commissioning/qualification of manufacturing systems.
• Strong knowledge of GMP, GAMP 5, FDA 21 CFR Parts 210/211, Part 11, and data integrity principles.
• Hands-on experience programming, configuring, and troubleshooting PLCs/HMIs, SCADA, and batch control platforms.
• Experience with Building Management Systems (BMS), historians, and integration of automation systems across sites.
• Experience with change management, deviation management, CAPAs, and quality systems in regulated environments.
• Familiarity with ERP/CMMS platforms (e.g., SAP) for work orders, calibration, and maintenance.
• Proven ability to communicate with technical and non-technical stakeholders; strong problem-solving skills.

Responsibilities

• Own end-to-end automation for the Canton site, including PLC/DCS, SCADA, HMI, and BMS lifecycles.
• Maintain validated state in GMP/GAMP 5 and Part 11 compliance, including lifecycle documentation.
• Provide technical leadership for troubleshooting and real-time manufacturing support.
• Lead deviation investigations, root-cause analysis, and CAPA implementation for automation.
• Drive continuous improvement through automation upgrades, risk reduction, and modernization.
• Support MSAT and tech transfer with automation readiness and data integrity.
• Manage automation aspects of capital projects from scope to handover to operations.
• Develop site automation standards, SOPs, PMs, and training for personnel.
• Coordinate external vendors and integrators to meet safety, quality, schedule, and budget.
• Serve as automation SME during audits and regulatory inspections.
• Collaborate with Quality, Validation, IT, and Engineering on change control and cybersecurity.
• Mentor engineers and technicians to build site capabilities.

Skills

Automation engineering

GMP/CSV expertise

PLC/SCADA/HMI

Regulatory compliance

Cross-functional collaboration

CAPA/deviation handling

Education

Bachelor's degree in Electrical, Chemical, Mechanical, Biochemical Engineering

Tools

Allen-Bradley/Rockwell PLCs

SCADA systems

SAP

Job description

Emergent Biosolutions in Canton, MA is recruiting a Senior Automation Engineer to own site-level automation, control systems, and lifecycle management for manufacturing facilities.

You will lead GMP-compliant automation strategies, support regulatory inspections, and drive continuous improvement across utilities, facilities, and manufacturing operations. This role requires hands-on PLC/SCADA expertise and a collaborative mindset to mentor engineers and coordinate with cross-functional teams.