Senior Process Optimization Engineer

Quva; 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 implementing complex process optimization and validation activities for our Texas site. You will drive deviation reduction projects, support scale-up, and develop technical documents to ensure readiness and compliance with FDA expectations.

You will collaborate with R&D, Manufacturing, Quality, Operations, and Regulatory teams to design experiments, analyze data, and deliver robust processes that meet growth and

Qualifications

• BS, MS, or PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or Biochemistry.
• 7+ years of experience in sterile drug manufacturing, technical operations, process validation, MS&T, or related functions.
• Experience in Airflow Visualization studies and programs in pharmaceutical industry.
• Experience supporting scale‑up, process improvement/efficiency projects, tech transfer, and manufacturing investigations.
• Exposure to regulatory submissions or CMC documentation is a plus.
• Demonstrated ability to work in fast‑paced environments undergoing growth or scale‑up.
• Must be authorized to work in the United States; sponsorship not available.

Responsibilities

• Lead cross functional teams to implement complex project improvement initiatives related to formulation and compounding including semi-automated systems.
• Development and implement the TX site air visualization program including coordination of various functional responsibilities from sterility, operations, and quality to ensure the program meets FDA expectations.
• Execute formulation and compounding feasibility studies using science based and risk-based methodologies to support process efficiency projects.
• Execute process validation and product transfer validations for new products and existing marketed products to support product lifecycle compliance.
• Partner with Manufacturing, MS&T, and Operations teams to troubleshoot deviations and develop CAPAs.
• Engage with Commercial Operations to ensure production processes meet customer requirements and on-time supply.
• Provide technical documentation such as Technical Assessments, Technical Position Papers, and Product Evaluations.
• Assist in product packaging configuration validations and shipping lane validations.

Skills

GMP knowledge

QbD principles

CMC expectations

Cross-functional leadership

Data interpretation

Technical writing

Project management

Airflow visualization

Education

Pharmaceutical Sciences

Chemical Engineering

Chemistry

Biochemistry

Tools

MS Office

Electronic documentation systems

Job description

Quva is seeking a Process Improvement Engineer II to lead cross-functional teams in implementing complex process optimization and validation activities for our Texas site. You will drive deviation reduction projects, support scale-up, and develop technical documents to ensure readiness and compliance with FDA expectations.

You will collaborate with R&D, Manufacturing, Quality, Operations, and Regulatory teams to design experiments, analyze data, and deliver robust processes that meet growth and