Process Development Engineer - MSAT

BW Design Group; Raleigh (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

BW Design Group is seeking a Process Development Engineer to support biotechnology and pharmaceutical clients with robust validation, technology transfer, troubleshooting, and manufacturing optimization.

The ideal candidate has 5–10 years in GMP environments, expertise in process/cleaning/equipment validation, and a strong knowledge of ICH Q8/Q9/Q10. You will work with cross-functional teams to ensure high-quality, compliant processes across diverse modalities.

Qualifications

• BS in a technical discipline related to pharmaceutical manufacturing.
• 5–10 years of experience in pharma/biotech GMP environments.
• Expertise in process, cleaning, and equipment validation.
• Knowledge of FDA/ICH Q8/Q9/Q10 guidelines and lifecycle approach.
• Experience with design spaces, control strategies, and DOE.

Responsibilities

• Prepare validation/qualification protocols and documents for new or modified processes, systems, or equipment.
• Conduct validation tests per internal/external standards.
• Develop validation master plans, process flow diagrams, and SOPs.
• Lead investigations and troubleshoot deviations; support technology transfer.
• Partner with regulatory affairs to align validation strategies with FDA expectations.
• Collaborate with manufacturing, quality, process development, and regulatory teams.

Skills

GMP experience

Process validation

DOE

Regulatory liaison

Cross-functional teams

Root cause analysis

Technology transfer

Documentation discipline

Education

B.S. in chemical/biomedical/pharma engineering

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.

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.

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 operation controls, in-process controls, and end-product specifications as defined in ICH Q10
• Lead investigations and perform troubleshooting following process deviations, trends, or issues, including designing and performing development studies at small- or full-scale to support technology transfer or investigations
• Develop, troubleshoot, and implement improvements to processes that enhance safety, robustness, efficiency, and cost performance
• Design and execute cleaning validation and optimization studies
• Conduct root-cause analysis and drive corrective actions
• Lead the transfer of drug substance processes to and from manufacturing facilities
• Evaluate and optimize processes to improve efficiency and quality
• Prepare, maintain, or review validation and compliance documentation
• Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems
• Partner with regulatory affairs to ensure validation strategies and control strategies meet current FDA expectations and ICH Q8/Q9/Q10 guidelines
• Partner with cross-functional client teams including manufacturing operations, quality, process development, and regulatory affairs

Experience

• B.S. or higher in a technical discipline related to pharmaceutical manufacturing (chemical engineering, biomedical engineering, pharmaceutical engineering, etc.)
• 5 to 10 years of experience in pharmaceutical or biotechnology GMP environment
• Demonstrated expertise in process, cleaning, and equipment validation
• Demonstrated knowledge of FDA regulatory requirements for process understanding and control, including ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)
• Track record of developing science-based control strategies and design spaces aligned with ICH Q8/Q9/Q10 principles
• Track record of hands‑on troubleshooting and rapid problem resolution in GMP environments
• Proven ability to quickly understand complex manufacturing systems and identify optimization opportunities

Technical Skills

• Understanding of GMP principles and FDA expectations for process validation and control strategy implementation
• Mastery of ICH Q8 principles: process understanding, design space development, parameter interactions, and lifecycle approach to pharmaceutical quality
• Proficiency in ICH Q9 Quality Risk Management methodologies including risk assessment, FMEA, and risk-based control strategy development
• Capability to implement ICH Q10 pharmaceutical quality system principles including integrated control strategies, continual improvement, and knowledge management
• Knowledge of FDA guidance documents on Process Validation (2011) and Process Understanding
• Design of experiments (DOE) and statistical analysis
• Data management and documentation systems
• Scale-up and technology transfer
• Upstream/downstream processing
• Strong communication and ability to clearly explain technical concepts to diverse audiences, including regulatory rationale and scientific justification for process controls to regulatory inspectors and clients
• Proven agility in learning new processes and equipment systems quickly
• Ability to manage multiple client deliverables
• Attention to detail with strong documentation discipline

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path.

As a Process Development Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world‑class engineer and a highly effective leader.