Location: Delaware
Reports To: Chief Technical Officer (CTO)
Position Overview
The Process Development Engineer will design, optimize, and scale manufacturing processes for GMPLI’s GMP-grade water, media, and buffer production. This role will focus on innovation, efficiency, and compliance to deliver consistent, high-quality products.
Key Responsibilities
- Develop and refine manufacturing processes to improve yield, quality, and throughput.
- Collaborate with Validation, Quality, and Operations to implement new processes.
- Support technology transfer from R&D or pilot scale to full production.
- Troubleshoot process deviations and implement corrective actions.
- Document process changes in compliance with GMP standards.
Qualifications
- Bachelor’s degree in Chemical Engineering, Bioprocess Engineering, or related field.
- 3+ years process development experience in pharmaceutical, biotech, or life sciences.
- Strong understanding of GMP, sterile manufacturing, and process scale-up.
- Proven problem-solving and project management skills.
Key Competencies
- Process Optimization
- Regulatory Compliance
- Innovation & Efficiency
- Cross-Functional Collaboration
- Technical Documentation