Senior Process Engineer, GMP Vaccine Manufacturing

Emergent BioSolutions; Canton (MA); On-site; USD 129,000 - 156,000; Full time

Job summary

Emergent BioSolutions is seeking a Sr Engineer, Process in Canton, MA to provide hands-on GMP process engineering support for vaccine drug substance manufacturing. This role will troubleshoot on the manufacturing floor, drive root cause analysis, and implement sustainable CAPAs to ensure uninterrupted operations.

You will own process systems, lead improvements, support technology transfers, and participate in validation activities while aligning with FDA/EMA expectations.

Qualifications

• Bachelor’s degree in chemical/biochemical/mechanical engineering.
• 7–10 years’ GMP process engineering experience in biopharmaceutical or vaccine manufacturing.
• Hands-on floor support in GMP environment.
• Strong knowledge of vaccine/biologics unit operations.
• Understanding of GMP regulations, validation lifecycle, change management, deviation management, and data integrity.
• Experience with process design and engineering documentation (PFDs, P&IDs, URS, FMEA).
• Ability to apply engineering fundamentals to complex problems using root cause and risk management.
• Effective communicator with cross-functional interfaces.
• Proficiency with AutoCAD, SAP, MS Office, and electronic quality systems.

Responsibilities

• Provide real-time process engineering support on the manufacturing floor for GMP vaccine operations.
• Lead troubleshooting of process/equipment deviations; identify root causes and implement CAPAs.
• Act as process owner for assigned unit operations and manufacturing systems.
• Lead process improvements, optimization, and capacity enhancements using data-driven approaches.
• Prepare and review GMP documents (deviations, change controls, risk assessments, protocols).
• Support technology transfer activities including process characterization and readiness for new/modifed processes.
• Lead commissioning, qualification, and validation activities for equipment and systems.
• Collaborate with Quality Assurance on data integrity and regulatory commitments.
• Provide process information during regulatory inspections as SME.
• Coordinate with vendors/contractors for equipment reliability and lifecycle management.
• Mentor junior engineers and contribute to engineering standards.

Skills

Process engineering

GMP familiarity

Troubleshooting

Root cause analysis

CAPA management

FDA/EMA compliance

Cross-functional collaboration

Process validation

Documentation

Equipment expertise

Education

Bachelor’s in Chemical/Biochemical/Mechanical engineering

MS/PhD preferred

Tools

AutoCAD

SAP

MS Office

Electronic QA systems

PFDs/P&IDs tools

Job description

Emergent BioSolutions is seeking a Sr Engineer, Process in Canton, MA to provide hands-on GMP process engineering support for vaccine drug substance manufacturing. This role will troubleshoot on the manufacturing floor, drive root cause analysis, and implement sustainable CAPAs to ensure uninterrupted operations.

You will own process systems, lead improvements, support technology transfers, and participate in validation activities while aligning with FDA/EMA expectations.