Process Engineer

📋 Description

• Provide aseptic process engineering support at external CMOs.
• Serve as aseptic processing SME during operations onsite when required.
• Lead investigations and CAPAs with root-cause analysis.
• Assess risk and manage change controls for manufacturing changes and filings.
• Ensure cGMP compliance and regulatory requirements for aseptic manufacturing.
• Lead tech transfer, CPPs/CQAs, and in‑process controls for aseptic ops.

🎯 Requirements

• Bachelor's in engineering or related field; 5+ years (Master's 3+).
• Aseptic drug product manufacturing exp for late-stage dev or commercial; device exp a plus.
• QbD, DoE, SPC, and data analysis proficiency.
• Familiarity with MATLAB or JMP for modeling/optimization.
• Detail‑oriented with strong problem solving and data trend analysis.
• Understanding of cGMP and regulatory requirements including validation.

🎁 Benefits

• Remote work opportunities in the United States with state restrictions.
• Travel to Cambridge, MA several times a year.
• Accommodations available for candidates needing them.
• Equal opportunity employer with inclusive hiring.