Process Development Engineer - MSAT

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

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description:

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Who You'll Work With

You will join one of our nearly 50 offices in the US, be part of a committed team of over 2000 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Process Development Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world's leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

Job Description:

This role supports biotechnology and pharmaceutical clients with robust equipment and process validation, technology transfer, troubleshooting, and manufacturing optimization. The ideal candidate demonstrates expertise across process, cleaning, and equipment validation domains, with a proven track record of leading complex projects and cross-functional teams in GMP environments. We seek someone with strong analytical and problem-solving capabilities to rapidly assess complex manufacturing challenges and drive operational excellence across diverse modalities.

Primary Responsibilities

• Prepare validation or performance qualification protocols, specifications, and associated 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 operati