Pharma GMP Manufacturing Engineer - Process & Validation

United Pharma; North Carolina; On-site; USD 85,000 - 120,000; Full time

Job summary

United Pharma is seeking an experienced Manufacturing Engineer to support GMP manufacturing operations in a Pharma/Biotech/Life Sciences setting. The role centers on process improvement, equipment, troubleshooting, validation, and ongoing quality enhancement.

Key responsibilities include supporting day-to-day GMP manufacturing, improving processes for quality and yield, and leading IQ/OQ/PQ activities along with CAPA and deviation handling.

Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Life Sciences, or related field.
• 3+ years of Manufacturing/Process Engineering in Pharma/Biotech.
• Experience in GMP manufacturing environment.
• Knowledge of process validation and equipment qualification (IQ/OQ/PQ).
• Experience with CAPA, deviations, change control, and root cause analysis.
• Strong problem-solving, data analysis, and technical documentation.
• Ability to work hands-on with cross-functional teams.

Responsibilities

• Support day-to-day GMP manufacturing operations and production activities.
• Improve processes to increase quality, efficiency, yield, and productivity.
• Troubleshoot equipment, process issues, and production problems.
• Support equipment installation, commissioning, qualification, and validation.
• Develop and execute IQ/OQ/PQ and process validation activities.
• Perform root cause analysis for manufacturing issues and deviations.
• Support CAPA, change controls, investigations, and corrective actions.
• Develop and maintain SOPs, work instructions, process specifications, and manufacturing documentation.
• Analyze process data and identify opportunities for continuous improvement.
• Support new equipment, process transfers, scale-up, and new product introduction.
• Ensure manufacturing activities comply with GMP, FDA, GxP, and company procedures.
• Collaborate with Manufacturing, Quality, Engineering, Validation, Automation, Facilities, and R&D teams.

Skills

Manufacturing Engineering

GMP compliance

Data analysis

Troubleshooting

IQ/OQ/PQ

CAPA & deviations

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Life Sciences

Job description

United Pharma is seeking an experienced Manufacturing Engineer to support GMP manufacturing operations in a Pharma/Biotech/Life Sciences setting. The role centers on process improvement, equipment, troubleshooting, validation, and ongoing quality enhancement.

Key responsibilities include supporting day-to-day GMP manufacturing, improving processes for quality and yield, and leading IQ/OQ/PQ activities along with CAPA and deviation handling.