Bend Bioscience · 12 hours ago
Senior Process Engineer
Gainesville, GA
Full-time
Onsite
Senior Level
5+ years expBend Bioscience is a people-centered company committed to advancing human health. In this role, you will serve as a technical leader in pharmaceutical manufacturing, driving process development, optimization, and scale-up efforts to support the reliable production of clinical and commercial drug products.
Pharmaceuticals
Responsibilities
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
Qualification
Required
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
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
Preferred
Process engineering and validation background
Company
Bend Bioscience
Bend Bioscience is a highly experienced contract development and manufacturing organization (CDMO) dedicated to advancing pharmaceutical innovation through cutting-edge scientific expertise and flexible problem-solving.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ajay Damani
Chief Executive Officer
David Vodak
Chief Science Officer
Company data provided by crunchbase