GMP Process Development Engineer (Validation)

barrywehmiller; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

BW Design Group, a Barry-Wehmiller company, seeks a Process Development Engineer to support biotech and pharmaceutical clients with robust validation, technology transfer, troubleshooting, and manufacturing optimization. The ideal candidate will demonstrate expertise across process, cleaning, and equipment validation in GMP environments and lead complex projects.

You will work with a team of industry experts to drive operational excellence and deliver high-quality solutions across diverse

Qualifications

• Experience in process, cleaning, and equipment validation in GMP environments.

Responsibilities

• Prepare validation or performance qualification protocols, specifications, and documentation for new or modified manufacturing processes, systems, or equipment
• Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards
• Develop validation master plans, process flow diagrams, test cases, or standard operating procedures
• Develop and document process understanding strategies aligned with ICH Q8 principles, including design space definition, parameter interaction mapping, and control strategy justification
• Execute quality risk management activities compliant with ICH Q9, including failure mode and effects analysis (FMEA), risk assessment, risk control implementation, and risk communication
• Establish and implement integrated control strategies combining unit operations

Skills

Analytical thinking

Problem solving

Cross-functional teams

GMP experience

Job description

BW Design Group, a Barry-Wehmiller company, seeks a Process Development Engineer to support biotech and pharmaceutical clients with robust validation, technology transfer, troubleshooting, and manufacturing optimization. The ideal candidate will demonstrate expertise across process, cleaning, and equipment validation in GMP environments and lead complex projects.

You will work with a team of industry experts to drive operational excellence and deliver high-quality solutions across diverse