Process Development Engineer - MSAT

Barry-Wehmiller • Raleigh, NC

9d

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 requires expertise in process, cleaning, and equipment validation, and involves leading complex projects and cross-functional teams in GMP environments. The engineer partners with manufacturing operations, quality, process development, regulatory affairs, and client teams to address manufacturing challenges and improve operational performance.

The role is part of Design Group’s Regulatory Compliance Practice. The engineer develops and executes validation strategies and documentation, applies ICH Q8, Q9, and Q10 principles, supports investigations and technology transfers, and evaluates manufacturing processes for safety, robustness, efficiency, and quality. The position also includes explaining technical concepts and scientific rationale to clients and regulatory inspectors, while managing multiple client deliverables.

Design Group describes a flexible, entrepreneurial work environment with professional development resources and mentorship, including its First Year Experience program, 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, biomedical, 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/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 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.
• Familiarity with data management and documentation systems, scale-up and technology transfer, and upstream/downstream processing.
• Strong communication skills and ability to explain technical concepts, regulatory rationale, and scientific justification for process controls to diverse audiences.
• Agility in learning new processes and equipment systems quickly.
• Ability to manage multiple client deliverables.
• Attention to detail and strong documentation discipline.

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 processes, equipment, or software in accordance with 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, 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 process 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 to identify root causes of production problems.
• Partner with regulatory affairs to ensure validation 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.
• Manage multiple client deliverables and communicate technical concepts and scientific rationale to diverse audiences, including regulatory inspectors and clients.

Benefits

• Professional development resources and mentorship, including the First Year Experience program, Individual Development Plans, and Career Path resources and tools.
• Flexible career path.

What This Job Offers

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