Sr. Process Engineer

In this role, you will serve as a technical leader in pharmaceutical manufacturing by driving process development, optimization, and scale-up efforts that support the reliable production of clinical and commercial drug products. You will ensure processes meet regulatory standards and contribute to cross-functional initiatives that enhance operational performance, product quality, and compliance in a highly regulated environment.

The Senior Process Engineer will also:

• Lead and execute scale-up, optimization, and technology transfer projects, collaborating with Research and Development (R&D) to implement processes into large-scale manufacturing.
• Serve as a subject matter expert on key unit operations and equipment, including, blending, dry granulation, wet granulation, fluid bed drying, Wurster/fluid bed coating, tableting, film coating, spray drying.
• Design and execute experiments to optimize pharmaceutical formulations and processes, using design of experiments (DoE), one-factor-at-a-time approaches, and risk-based planning.
• Develop and manage documentation including Performance Qualification (PQ) protocols, risk assessments, Standard Operating Procedures (SOPs), and Manufacturing Batch Records for developmental and clinical use and development reports.
• Conduct process validation, cleaning validation, and perform gap analyses, Failure Modes and Effects Analyses (FMEAs), and risk assessments to ensure compliance with current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) guidelines, United States Pharmacopeia (USP), International Society for Pharmaceutical Engineering (ISPE), and International Organization for Standardization (ISO) standards.
• Analyze process data, perform capability studies, and design experiments to support new product implementation and continuous improvement.
• Investigate and implement workflow and equipment improvements to enhance accuracy, efficiency, and reliability across departments.
• Provide technical support and troubleshooting expertise to maintenance and operations teams for equipment and process issues.
• Author manufacturing deviations and Corrective and Preventive Actions (CAPAs), and lead technical risk assessments to support quality and regulatory compliance.
• Train process engineers and manufacturing personnel on equipment, procedures, and safety practices.
• Apply Lean Manufacturing principles and manage projects to deliver results on time and within budget.
• Professional Conduct and Workplace Culture: Ensure full-time attendance, exhibit professionalism with business associates, and align daily actions with organizational values.
• Perform all other duties as assigned.

Education and Experience

• Bachelors in engineering, science or related field

• Minimum Required: 10 plus years in regulated pharmaceutical organization that includes solid dose formulations OR Masters in an engineering discipline and 5 years of related experience

• Preferred: Process engineering and validation background.

Knowledge, Skills, and Abilities

• Demonstrates initiative and reliability by independently completing tasks that support team objectives and operational goals.
• Communicates clearly, respectfully, and effectively across departments to relay technical information, responsibilities, and policies.
• Apply critical thinking and problem-solving skills to evaluate complex issues from multiple perspectives and implement practical solutions.
• Collaborate effectively in cross-functional teams to support manufacturing operations and process development activities.
• Utilizes electronic management systems for equipment tracking and quality documentation, with working knowledge of current Good Manufacturing Practices (cGMP) and United States Food and Drug Administration (FDA) regulations.
• Apply engineering principles to support the operation, troubleshooting, and optimization of production equipment, contributing to process reliability and efficiency.
• Maintains adaptability and accountability in a regulated environment, ensuring compliance and continuous improvement in support of clinical and commercial manufacturing.
• Proficiency in Microsoft Suite including Word, Excel, PowerPoint, and role related software.