Sr Engineer, Automation
Emergent BioSolutions
August 12, 2026
On-site
Canton, MA
IT
Job Summary
The Senior Automation Engineer is the site-level technical authority and owner for all aspects of automation, control systems, and computerized systems at the Canton, MA GMP Vaccine Drug Substance manufacturing site. Accountable for reliability, compliance, lifecycle management, and continuous improvement of process, utility, and facility automation systems supporting commercial and clinical vaccine manufacturing.
Essential Functions
- Serve as automation system owner for the Canton site (process control, PLC/DCS, SCADA, HMI, batch systems, BMS, historians) through lifecycle.
- Ensure automation systems remain validated in compliance with GMP, GAMP 5, 21 CFR Parts 210/211, and Part 11; author/review/approve lifecycle documentation (URS/FRS/DDS, risk assessments, commissioning & qualification protocols/reports).
- Lead troubleshooting of complex automation/control/integration issues to minimize downtime.
- Lead/support deviation investigations, root cause analysis, and CAPA implementation for automation/computerized systems.
- Drive continuous improvement via automation enhancements, risk reduction, standardization, and legacy modernization.
- Support MSAT and technology transfer by ensuring automation readiness, scalability, data integrity, and alignment to new/modified processes.
- Manage automation scope for capital projects (vendor selection, design review, integration, commissioning/qualification, handover).
- Develop/maintain automation standards, procedures, SOPs, PMs; provide training as needed.
- Coordinate/manage integrators, vendors, consultants, and contractors.
- Serve as site automation SME during audits/inspections/regulatory interactions.
- Partner with Quality, Validation, IT, and Engineering for change control, data integrity, cybersecurity, and inspection readiness.
- Provide technical mentorship to engineers/technicians.
Minimum Education/Experience/Skills
- Bachelor’s in Electrical, Chemical, Mechanical, Biochemical Engineering, or related; advanced degree preferred.
- 8+ years progressive GMP automation engineering in pharma/biologics/vaccine manufacturing; DS and/or vaccine experience strongly preferred.
- Expertise in GMP automation, CSV, and commissioning/qualification.
- Knowledge of GMP, GAMP 5, FDA 21 CFR Parts 210/211, Part 11, and data integrity.
- Hands-on PLC/HMI (Allen‑Bradley/Rockwell preferred), SCADA, batch control, and process instrumentation.
- Experience with BMS, process historians, and automation integration.
- Experience with change management, deviation management, CAPAs, and quality systems.
- Familiarity with ERP/CMMS (e.g., SAP).
- Cross-functional communication; strong analytical/problem-solving and prioritization.
Relocation
- Relocation eligible within the United States.
Application Instruction
- Before an interview is scheduled, discuss interest in the role with your current manager if the hiring manager requests an interview.
The Senior Automation Engineer is the site-level technical authority and owner for all aspects of automation, control systems, and computerized systems at the Canton, MA GMP Vaccine Drug Substance manufacturing site. Accountable for reliability, compliance, lifecycle management, and continuous improvement of process, utility, and facility automation systems supporting commercial and clinical vaccine manufacturing.
Essential Functions
- Serve as automation system owner for the Canton site (process control, PLC/DCS, SCADA, HMI, batch systems, BMS, historians) through lifecycle.
- Ensure automation systems remain validated in compliance with GMP, GAMP 5, 21 CFR Parts 210/211, and Part 11; author/review/approve lifecycle documentation (URS/FRS/DDS, risk assessments, commissioning & qualification protocols/reports).
- Lead troubleshooting of complex automation/control/integration issues to minimize downtime.
- Lead/support deviation investigations, root cause analysis, and CAPA implementation for automation/computerized systems.
- Drive continuous improvement via automation enhancements, risk reduction, standardization, and legacy modernization.
- Support MSAT and technology transfer by ensuring automation readiness, scalability, data integrity, and alignment to new/modified processes.
- Manage automation scope for capital projects (vendor selection, design review, integration, commissioning/qualification, handover).
- Develop/maintain automation standards, procedures, SOPs, PMs; provide training as needed.
- Coordinate/manage integrators, vendors, consultants, and contractors.
- Serve as site automation SME during audits/inspections/regulatory interactions.
- Partner with Quality, Validation, IT, and Engineering for change control, data integrity, cybersecurity, and inspection readiness.
- Provide technical mentorship to engineers/technicians.
Minimum Education/Experience/Skills
- Bachelor’s in Electrical, Chemical, Mechanical, Biochemical Engineering, or related; advanced degree preferred.
- 8+ years progressive GMP automation engineering in pharma/biologics/vaccine manufacturing; DS and/or vaccine experience strongly preferred.
- Expertise in GMP automation, CSV, and commissioning/qualification.
- Knowledge of GMP, GAMP 5, FDA 21 CFR Parts 210/211, Part 11, and data integrity.
- Hands-on PLC/HMI (Allen‑Bradley/Rockwell preferred), SCADA, batch control, and process instrumentation.
- Experience with BMS, process historians, and automation integration.
- Experience with change management, deviation management, CAPAs, and quality systems.
- Familiarity with ERP/CMMS (e.g., SAP).
- Cross-functional communication; strong analytical/problem-solving and prioritization.
Relocation
- Relocation eligible within the United States.
Application Instruction
- Before an interview is scheduled, discuss interest in the role with your current manager if the hiring manager requests an interview.