Process Optimization Engineer II

oneQuva; Sugar Land (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Quva is seeking a Process Improvement Engineer II to lead cross-functional teams in developing and implementing process efficiency projects. The role involves airflow visualization studies essential for cleanroom validation and contamination controls, along with supporting regulatory readiness and technology transfer across sites.

The candidate will drive deviation reduction, CAPA development, and data-driven process characterizations while collaborating with R&D, Quality, Operations, and

Qualifications

• BS, MS, or PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related field.
• 7+ years in sterile drug manufacturing, technical operations, process validation, MS&T, or related functions.
• Experience with Airflow Visualization studies and programs in pharma.
• Experience supporting scale-up, process improvement, tech transfer, and investigations.

Responsibilities

• Lead cross-functional teams to implement complex process improvement initiatives.
• Develop and manage TX site air visualization program in collaboration with sterility, ops, and quality.
• Execute feasibility studies and validations for new products and processes.
• Partner with manufacturing and MS&T to troubleshoot deviations and CAPA.
• Provide hands-on execution of scale-up activities and process transfers.

Skills

Process improvement

Cross-functional leadership

Project management

Deviation reduction

Validation

Technical writing

Airflow visualization

Scale-up

Regulatory submissions

CAPA

Education

BS in Pharmaceutical Sciences

MS/PhD in Chemical Engineering

Tools

Airflow Visualization studies

Job description

Quva is seeking a Process Improvement Engineer II to lead cross-functional teams in developing and implementing process efficiency projects. The role involves airflow visualization studies essential for cleanroom validation and contamination controls, along with supporting regulatory readiness and technology transfer across sites.

The candidate will drive deviation reduction, CAPA development, and data-driven process characterizations while collaborating with R&D, Quality, Operations, and