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. This role is accountable for ensuring the reliability, compliance, lifecycle management, and continuous improvement of process, utility, and facility automation systems supporting commercial and clinical vaccine manufacturing.
The position requires deep hands-on expertise with GMP automation in biologics/vaccine environments and close collaboration with Manufacturing, MSAT, Quality, Validation, Facilities, and Capital Projects teams. The Senior Automation Engineer will lead automation strategy, support deviation investigations and CAPAs, enable process improvements, support technology transfer activities, and serve as the primary subject matter expert (SME) during internal and external regulatory inspections.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Serve as the automation system owner for the Canton site, with end-to-end responsibility for process control, PLC/DCS, SCADA, HMI, Batch systems, Building Management Systems (BMS), historians, and associated infrastructure throughout their lifecycle (design through retirement).
- Ensure all automation systems remain in a validated state in compliance with GMP, GAMP 5, 21 CFR Parts 210, 211, and Part 11 requirements, including authoring, reviewing, and approving system lifecycle documentation (URS, FRS, DDS, risk assessments, commissioning and qualification protocols, reports).
- Provide technical leadership for troubleshooting complex automation, control, and integration issues impacting manufacturing operations, utilities, and facilities; support manufacturing in real-time to minimize downtime and ensure product supply.
- Lead and support deviation investigations, root cause analysis, and CAPA implementation related to automation and computerized systems.
- Drive continuous improvement and process optimization initiatives through automation enhancements, risk reduction, standardization, and modernization of legacy systems.
- Actively support process improvement, MSAT, and technology transfer efforts by ensuring automation readiness, scalability, data integrity, and alignment with new or modified manufacturing processes.
- Manage and oversee automation activities for capital projects, including scope development, vendor selection, design review, integration, commissioning, qualification, and handover to operations.
- Develop and maintain site automation standards, procedures, SOPs, PMs, and engineering best practices; provide training to operations, engineering, and maintenance personnel as required.
- Coordinate and manage external system integrators, vendors, consultants, and contractors to ensure delivery meets safety, quality, schedule, and budget expectations.
- Serve as the site automation SME during audits, inspections, and regulatory interactions, including direct engagement with regulatory agencies as required.
- Partner closely with Quality, Validation, IT, and Engineering to support change control, data integrity, cybersecurity, and inspection readiness activities.
- Provide technical mentorship and guidance to other engineers and technicians, contributing to capability building and knowledge retention at the site.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.Bachelor's degree in Electrical, Chemical, Mechanical, Biochemical Engineering, or a related engineering discipline; advanced degree preferred.
- Minimum of 8 years of progressive automation engineering experience within a GMP-regulated pharmaceutical, biologics, or vaccine manufacturing environment; direct Drug Substance (DS) and/or vaccine experience strongly preferred.
- Demonstrated expertise in GMP automation, computer system validation (CSV), and commissioning and qualification of manufacturing systems.
- Strong knowledge of regulatory and industry standards including GMP, GAMP 5, FDA 21 CFR Parts 210/211, Part 11, and data integrity principles.
- Hands-on experience programming, configuring, and troubleshooting PLCs and HMIs (Allen-Bradley/Rockwell preferred), SCADA systems, batch control platforms, and process instrumentation.
- Proven experience with Building Management Systems (BMS), process historians, and integration of automation systems across manufacturing, utilities, and facilities.
- Experience with change management systems, deviation management, CAPAs, and quality systems within regulated environments.
- Familiarity with ERP/CMMS platforms (e.g., SAP) for work orders, calibration, and maintenance management.
- Proven ability to work cross-functionally, communicate effectively with technical and non-technical stakeholders, and lead complex technical discussions.
- Strong analytical, problem-solving, and decision-making skills with the ability to prioritize in a fast-paced manufacturing environment.
If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled.
U.S. Base Pay Ranges and Benefits Information
The estimated annual base salary as a new hire for this position ranges from $150,000 to $181,500. 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.]
Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent
(*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.
