Engineer II, Process Engineering, Filling Operations

As a Process Engineer II supporting aseptic filling, visual inspection, and secondary packaging operations at the Norwood, MA site, you will provide day-to-day engineering support to ensure safe, compliant, and reliable manufacturing operations. Working closely with Manufacturing, Quality, MS&T, Validation, Automation, and Facilities, you will troubleshoot equipment issues, support investigations, execute continuous improvement initiatives, and participate in equipment qualification and lifecycle management within a GMP environment. This position is hands-on and focused on equipment reliability, process optimization, and operational excellence while developing technical expertise under the guidance of senior engineers. Here’s What You’ll Do Equipment Support & Reliability Support process and equipment ownership for aseptic filling lines, isolators/RABS, formulation skids, component preparation equipment, visual inspection systems, labeling, packaging equipment, and supporting utilities. Monitor equipment performance using reliability and operational KPIs including OEE, downtime, rejects, and recurring equipment events. Support preventive maintenance optimization, spare parts identification, CMMS updates, and equipment lifecycle documentation. Participate in equipment inspections and recommend improvements to enhance reliability. Troubleshooting & Investigations Troubleshoot equipment and process issues during manufacturing. Support deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs). Utilize structured problem-solving tools including 5-Why and Fishbone analysis to identify equipment and process improvements. Collaborate with cross-functional teams to resolve manufacturing issues while minimizing production impact. Automation & Process Improvements Support equipment recipe changes, parameter optimization, and automation improvements through approved change control processes. Analyze equipment performance and production data to identify trends and opportunities for improvement. Assist with implementation of process improvements that improve equipment performance, product quality, and operational efficiency. Qualification & Projects Support commissioning, FAT/SAT, IQ/OQ/PQ, and equipment validation activities. Execute assigned engineering projects including equipment upgrades, process improvements, and change controls. Coordinate vendor activities during maintenance and project execution. Maintain engineering documentation including SOPs, specifications, and technical reports. GMP Compliance Ensure equipment and processes comply with GMP requirements, site procedures, and regulatory expectations. Support audit readiness activities and assist during internal and external inspections. Follow Good Documentation Practices (GDP), ALCOA+, and data integrity requirements. Operations Support Provide on-floor engineering support during manufacturing operations. Develop troubleshooting documentation and standard work instructions. Support operator and maintenance training on equipment and process improvements. Participate in after-hours or on-call support as required. Here’s What You’ll Need (Basic Qualifications) Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering discipline. Typically 2–5 years of experience in GMP pharmaceutical manufacturing, process engineering, manufacturing engineering, or equipment engineering. Experience supporting manufacturing equipment in regulated environments. Strong troubleshooting and analytical problem-solving skills. Ability to work effectively in a fast-paced, cross-functional manufacturing environment. This position is site-based in Norwood, MA and is not eligible for remote work. Here’s What You’ll Bring to the Table (Preferred Qualifications) Experience supporting aseptic filling, isolators, visual inspection, packaging, or pharmaceutical process