Engineer II, Process Engineering, Filling Operations

Support aseptic filling, visual inspection, and secondary packaging operations at the Norwood, MA site by providing day-to-day engineering support to ensure safe, compliant, and reliable manufacturing operations. Collaborate with Manufacturing, Quality, MS&T, Validation, Automation, and Facilities to troubleshoot equipment issues, support investigations, execute continuous improvement initiatives, and participate in equipment qualification and lifecycle management within a GMP environment.

Responsibilities

• 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.

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.

Preferred Qualifications

• 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 to support unique needs.
• 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 a discretionary year-end shutdown.
• Savings and investments to help plan for the future.
• Location-specific perks and extras.

Pay

The salary range for this role is $74,000.00 - $118,400.00. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.