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.

Responsibilities

Provide day-to-day engineering support for aseptic filling, visual inspection, and secondary packaging operations; 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; Troubleshoot equipment and process issues during manufacturing; Support deviation investigations, root cause analysis, and implementation of CAPAs; Utilize structured problem-solving tools including 5-Why and Fishbone analysis; Support equipment recipe changes, parameter optimization, and automation improvements through approved change control; Support commissioning, FAT/SAT, IQ/OQ/PQ, and equipment validation activities; Execute assigned engineering projects including equipment upgrades, process improvements, and change controls; Ensure equipment and processes comply with GMP requirements, site procedures, and regulatory expectations; Provide on-floor engineering support during manufacturing operations; Develop troubleshooting documentation and standard work instructions; Support operator and maintenance training

Requirements

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

Nice to have

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

Benefits

Competitive healthcare plus voluntary benefit programs; Holistic approach to well-being with access to fitness, mindfulness, and mental health support; Family planning benefits including fertility, adoption, and surrogacy support; Generous paid time off including vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown; Savings and investments; Location-specific perks and extras; Eligible for annual discretionary bonus, other incentive compensation, or equity award