GMP Process Engineer — CQV, Validation & Optimization

GxP Associates; Pennsylvania; On-site; USD 90,000 - 120,000; Full time

Job summary

GxP Associates in the United States is seeking an experienced Process Engineer to support GMP manufacturing operations in a cGMP‑regulated pharmaceutical/biotech facility. The role focuses on technical support for manufacturing processes, equipment, process improvements, troubleshooting, and qualification activities for clinical and commercial production.

The candidate will work with Manufacturing, Engineering, Quality, CQV, Facilities, and external vendors to ensure processes remain robust,

Qualifications

• 2–5 years of process engineering experience in regulated pharma environments.
• Bachelor degree in Chemical/biochemical engineering or related field.
• Hands-on GMP experience with manufacturing processes and equipment.

Responsibilities

• Provide day-to-day technical and engineering support to GMP manufacturing operations.
• Support development, implementation, and optimization of manufacturing processes and equipment.
• Assist with qualification activities (IQ/OQ/PQ) and validations.
• Collaborate with QA, CQV, Facilities, and external vendors to ensure compliant operations.
• Analyze process data to identify improvements and optimize efficiency.

Skills

cGMP knowledge

Process engineering

Root cause investigations

Change controls

IQ/OQ/PQ

FMEA

CAPA

Technical writing

Documentation

Data analysis

Education

Bachelor's degree in Chemical Engineering or related

Tools

TrackWise

Maximo

CMMS

Job description

GxP Associates in the United States is seeking an experienced Process Engineer to support GMP manufacturing operations in a cGMP‑regulated pharmaceutical/biotech facility. The role focuses on technical support for manufacturing processes, equipment, process improvements, troubleshooting, and qualification activities for clinical and commercial production.

The candidate will work with Manufacturing, Engineering, Quality, CQV, Facilities, and external vendors to ensure processes remain robust,