Process Engineer

Responsibilities

• Support technical leadership and day-to-day aseptic process engineering support for clinical and commercial drug product manufacturing at external CMOs.
• Serve as the aseptic processing SME during manufacturing operations providing onsite support when required.
• Lead investigations, perform rigorous root cause analysis and develop scientifically sound CAPAs, ensuring alignment with regulatory expectations and industry best practices.
• Assess and author technical risk assessments and change controls to support manufacturing changes, investigations, and regulatory filings.
• Ensure strict compliance with cGMPs, global regulatory requirements, and internal quality systems for aseptic manufacturing.
• Lead and support aseptic drug product technology transfer activities from development to clinical and commercial manufacturing sites.
• Define and transfer critical process parameters (CPPs), critical quality attributes (CQAs), and in-process controls for aseptic unit operations.
• Develop and execute aseptic process validation strategies, including PPQ planning, statistical sampling plans, and acceptance criteria aligned with regulatory guidance.
• Provide technical authorship and review for regulatory submissions (IND, BLA, NDA, MAA), validation reports, and responses to regulatory agency questions.
• Support new product introductions and commercial launches by ensuring validated, scalable, and inspection-ready aseptic processes.
• Lead continued process verification (CPV) and routine data trending for aseptic unit operations, environmental monitoring, and critical process parameters.
• Develop and maintain data repositories, dashboards, and meaningful KPIs to assess aseptic process capability and performance.
• Identify early signals of process drift or increased contamination risk and proactively drive corrective or preventive actions.
• Prepare and present quarterly CPV summaries and technical assessments for internal management reviews.
• Identify and execute continuous improvement initiatives focused on aseptic process robustness, sterility assurance, capacity, and operational efficiency.
• Apply Quality by Design (QbD), statistical tools, and risk-based decision making to optimize aseptic manufacturing processes.
• Collaborate with CMOs to implement best practices, new technologies, or process enhancements where appropriate.

Requirements

• Bachelor’s degree in engineering or related field with 5+ years of relevant experience, or Master’s with 3+ years of relevant experience.
• Prior experience in aseptic drug product manufacturing for late-stage development/commercial is required. Device experience is a plus.
• Proficiency in Quality by Design (QbD), Design of Experiments (DoE), statistical process control (SPC), and complex data analysis.
• Familiarity with modeling and optimization tools (e.g., MATLAB, JMP).
• Detail-oriented with strong problem-solving skills and ability to identify subtle trends in data.
• Comprehensive understanding of cGMP principles and regulatory requirements, including process, equipment, and facility validation.
• Excellent communication and teamwork skills.
• Ability to travel to domestic and international CMOs as needed.