Engineer II, Process Engineering, Filling Operations

Process Engineer II

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Experience supporting aseptic filling, isolators, visual inspection, packaging, or pharmaceutical process equipment.
• Working knowledge of GMP regulations, Annex 1, Good Documentation Practices, and ALCOA+ principles.
• Familiarity with CMMS systems (Maximo preferred) and electronic batch records.
• Experience supporting qualification protocols (IQ/OQ/PQ).
• Basic knowledge of reliability metrics, OEE, and preventive maintenance strategies.
• Experience using structured problem-solving methodologies such as 5-Why or Fishbone.
• Strong communication, organization, and technical writing skills.
• Proficiency with Microsoft Excel and basic data analysis tools.
• Experience supporting change control and deviation systems is preferred.