Process Engineer II (Manufacturing Sciences)

About the role

Genetix Biotherapeutics is seeking a Process Engineer II to join its Manufacturing Sciences and Technology (MSAT) team. This full‑time hybrid position supports technology transfer, GMP production of autologous cell therapies, and ongoing commercial manufacturing.

Key responsibilities

• Serve as the primary technical expert for GMP production at CDMO partners.
• Lead complex manufacturing investigations using root‑cause analysis and develop corrective and preventive actions.
• Develop and maintain process trending and continued process verification programs.
• Drive continuous‑improvement projects that enhance process performance.
• Coordinate cross‑functional tech‑transfer teams and track program progress.
• Prepare and review technical documentation such as process descriptions, sampling plans, risk assessments, and study protocols.
• Apply statistical tools for data analysis to identify variability sources and resolve failures.
• Provide hands‑on support for tech‑transfer and GMP runs as the lead Person in Plant (PiP).
• Oversee engineering and process performance qualification (PPQ) runs to successful completion.

Required profile

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
• 3–5 years of experience in GMP manufacturing, cell‑therapy processes, or related biopharmaceutical environments.

Required skills

• GMP/cGMP manufacturing expertise.
• Root‑cause analysis and corrective‑action development.
• Process trending and continued process verification.
• Statistical analysis and data‑interpretation tools.
• Technology transfer and cross‑functional team leadership.
• Process performance qualification (PPQ) execution.
• Risk assessment and technical documentation preparation.

What we offer

• Hybrid work model (3 days onsite per week).
• Opportunity to contribute to curative gene‑therapy development.
• Collaborative, values‑driven culture focused on innovation and patient impact.