Sr Engineer, Process

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

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Canton, MA, US, 02021 Canton, MA, US, 02021

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

The Sr Engineer, Process is a key technical leader supporting GMP vaccine drug substance manufacturing operations. This role provides hands-on process engineering support to ensure safe, reliable, and compliant manufacturing across upstream and downstream operations. The Senior Process Engineer is accountable for real-time troubleshooting of process and equipment issues on the manufacturing floor, driving rapid root cause identification and sustainable solutions while maintaining uninterrupted GMP operations.

This position partners closely with Manufacturing, MS&T, Quality, Automation, and Facilities to support commercial manufacturing, technology transfers, process optimization, deviation investigations, and change management. The role also provides engineering ownership across the process lifecycle, including process design, scale-up, equipment specification, commissioning, qualification, and continued process verification in compliance with FDA, EMA, and global regulatory expectations

ESSENTIAL FUNCTIONS

• Provide direct, real-time process engineering support on the manufacturing floor for GMP vaccine drug substance operations, including upstream, downstream, and process support systems.
• Lead and execute troubleshooting of process and equipment deviations, collaborating with cross-functional teams to identify root causes and implement effective CAPAs.
• Serve as process owner and subject matter expert (SME) for assigned unit operations and manufacturing systems, ensuring robust and compliant operation.
• Support and lead process improvements, optimization initiatives, and capacity enhancements using data-driven and risk-based approaches.
• Author, review, and approve GMP documentation including deviations, change controls, process risk assessments, protocols, reports, and regulatory-facing technical documentation.
• Support technology transfer activities, including process characterization, equipment fit assessments, and operational readiness for new or modified processes.
• Lead or execute commissioning, qualification, and validation activities for process equipment and systems, including support of FATs, SATs, and PPQ.
• Partner with Quality Assurance to ensure alignment with Quality Systems, data integrity requirements, and regulatory commitments.
• Provide technical input during regulatory inspections and audits and present process and equipment information as a subject matter expert.
• Collaborate with vendors, contractors, and internal engineering groups to support equipment reliability, lifecycle management, and continuous improvement.
• Mentor junior engineers and contribute to engineering standards, best practices, and knowledge sharing across the site.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor’s degree in Chemical, Biochemical, Mechanical, or related Engineering discipline; advanced degree preferred.
• Minimum of 7–10 years of progressive process engineering experience in GMP-regulated biopharmaceutical or vaccine drug substance manufacturing.
• Demonstrated hands-on experience supporting manufacturing operations, including real-time troubleshooting and floor support in a GMP environment.
• Strong working knowledge of vaccine or biologics unit operations, including upstream processing, downstream purification, formulation, CIP/SIP, and single-use technologies.
• In-depth understanding of GMP regulations, validation lifecycle, change management, deviation management, and data integrity principles.
• Proven experience with process design and engineering documentation such as PFDs, P&IDs, URS, FMEA, and equipment specifications.
• Ability to apply engineering fundamentals to complex manufacturing problems using structured root cause and risk management tools.
• Effective communicator with the ability to interface with Manufacturing, Quality, Regulatory, and senior leadership.
• Proficiency with common engineering and enterprise systems (e.g., AutoCAD, MS Office, electronic quality systems, SAP preferred).
• Ability to work in a fast-paced manufacturing environment and provide on-call or off-shift support as needed to ensure uninterrupted operations.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $129,000 to $156,000. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant’s geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Emergent prepares those entrusted with protecting their communities against current and future health threats.

Our drive towards this vision informs all of our actions- whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community, we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • We are engaged and accountable for delivering on our commitments.
• Breakthrough thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.