Process Development Engineer - MSAT

Barry-Wehmiller • Raleigh, NC

1d

About The Position

The Process Development Engineer supports biotechnology and pharmaceutical clients with equipment and process validation, technology transfer, troubleshooting, and manufacturing optimization. The role is part of the Regulatory Compliance Practice and involves working with client teams and subject matter experts to deliver accurate, high-quality solutions in GMP environments.

The engineer leads and performs work across process, cleaning, and equipment validation, including preparing protocols and documentation, conducting qualification tests, developing process understanding and control strategies, and applying quality risk management. The role also supports investigations, root-cause analysis, corrective actions, cleaning studies, process improvements, and drug substance process transfers between manufacturing facilities. The engineer analyzes validation data and works with manufacturing operations, quality, process development, and regulatory affairs to ensure strategies align with FDA expectations and ICH Q8, Q9, and Q10 guidelines.

The position calls for strong analytical and problem-solving capabilities, clear communication with diverse audiences, attention to documentation, and the ability to understand complex manufacturing systems, manage multiple client deliverables, and identify optimization opportunities. Design Group describes a flexible, growth-oriented culture with professional development resources, mentorship, Individual Development Plans, and Career Path resources and tools.

Requirements

• B.S. or higher in a technical discipline related to pharmaceutical manufacturing, such as chemical engineering, biomedical engineering, or pharmaceutical engineering.
• 5 to 10 years of experience in a pharmaceutical or biotechnology GMP environment.
• Demonstrated expertise in process, cleaning, and equipment validation.
• Knowledge of FDA regulatory requirements for process understanding and control, including ICH Q8, ICH Q9, and ICH Q10.
• Track record of developing science-based control strategies and design spaces aligned with ICH Q8, Q9, and Q10 principles.
• Track record of hands-on troubleshooting and rapid problem resolution in GMP environments.
• Ability to quickly understand complex manufacturing systems and identify optimization opportunities.
• Understanding of GMP principles and FDA expectations for process validation and control strategy implementation.
• Mastery of ICH Q8 principles, including process understanding, design space development, parameter interactions, and the 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.
• Knowledge of design of experiments (DOE) and statistical analysis.
• Knowledge of data management and documentation systems.
• Knowledge of scale-up and technology transfer.
• Knowledge of upstream and downstream processing.
• Strong communication skills and ability to explain technical concepts to diverse audiences.
• Agility in learning new processes and equipment systems quickly.
• Attention to detail and strong documentation discipline.

Responsibilities

• Prepare validation or performance qualification protocols, specifications, and related documentation for new or modified manufacturing processes, systems, or equipment.
• Conduct validation or qualification tests of processes, equipment, or software according to internal protocols or external standards.
• Develop validation master plans, process flow diagrams, test cases, and standard operating procedures.
• Develop and document process understanding strategies aligned with ICH Q8, including design space definition, parameter interaction mapping, and control strategy justification.
• Perform ICH Q9-compliant quality risk management activities, including 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 in alignment with ICH Q10.
• Lead investigations and troubleshoot deviations, trends, or issues; design and perform development studies at small or full scale to support technology transfer or investigations.
• Develop, troubleshoot, and implement process improvements to enhance safety, robustness, efficiency, and cost performance.
• Design and execute cleaning validation and optimization studies.
• Conduct root-cause analysis and drive corrective actions.
• Lead 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 meet validation criteria and identify root causes of production problems.
• Partner with regulatory affairs to align validation and control strategies with current FDA expectations and ICH Q8, Q9, and Q10 guidelines.
• Partner with cross-functional client teams, including manufacturing operations, quality, process development, and regulatory affairs.
• Manage multiple client deliverables and communicate technical concepts, regulatory rationale, and scientific justification to clients and regulatory inspectors.

Benefits

• Professional development resources and mentorships, including the First Year Experience program, Individual Development Plans, and Career Path resources and tools.
• A highly flexible, rewarding, and challenging career path.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior