Senior Process Improvement Engineer – GMP & Validation

RXinsider LTD.; New Jersey; On-site; USD 99,000 - 136,000; Full time

Benefits offered by this job

Health benefits

401k retirement plan

PTO and holidays

Job summary

Quva seeks a Process Improvement Engineer II to lead cross‑functional teams in formulating and implementing complex process enhancements at the NJ site. The role involves development of airflow visualization studies, facilitating regulatory readiness and ensuring timely supply, while collaborating with R&D, Manufacturing, Quality, and Regulatory groups.

The ideal candidate has extensive experience in GMP/CMC, process validation, tech transfer, and data-driven decision making, with strong

Qualifications

• BS, MS, or PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related field.
• 7+ years of experience in sterile drug manufacturing, technical operations, process validation, MS&T, or related functions.
• Experience with airflow visualization studies in pharma industry.
• Exposure to regulatory submissions or CMC documentation is a plus.

Responsibilities

• Lead cross-functional teams to implement complex project improvement initiatives.
• Develop and implement NJ site air visualization program coordinating sterility, operations and quality.
• Execute formulation and compounding feasibility studies to support process improvements.
• Perform process validations and product transfers for new and existing products.
• Troubleshoot deviations and CAPA to maintain compliance and production readiness.

Skills

GMP compliance

ICH guidelines

QbD principles

CMC expectations

Data analysis

Project management

Technical writing

Cross-functional leadership

Education

BS/MS/PhD in Pharmaceutical Sciences or Chemical Engineering

Tools

MS Office

Electronic documentation systems

Job description

Quva seeks a Process Improvement Engineer II to lead cross‑functional teams in formulating and implementing complex process enhancements at the NJ site. The role involves development of airflow visualization studies, facilitating regulatory readiness and ensuring timely supply, while collaborating with R&D, Manufacturing, Quality, and Regulatory groups.

The ideal candidate has extensive experience in GMP/CMC, process validation, tech transfer, and data-driven decision making, with strong