Process Engineer, Technical Operations - Small Molecule Drug Substance

About the role

We are seeking a Process Engineer, Technical Operations - Drug Substance to join our dynamic team. This role offers the opportunity to support the design, commissioning, qualification, and startup readiness of a capital project, while also contributing to technology transfers and commercial manufacturing.

Responsibilities

• Technical & Process Support
• Support the Capital Project Team
• Provide technical support for API manufacturing processes
• Support process scale-up, technology transfer, and validation activities
• Analyze process data to support performance monitoring, troubleshooting, and improvement
• Take ownership of assigned process equipment and manufacturing processes
• Provide on-the-floor technical support during manufacturing campaigns
• Technology Transfer & Commercialization Support
• Execute technology transfers for new products and processes
• Contribute to process fit assessments, scale-up readiness, and manufacturability evaluations
• Support development and review of batch documentation and process instructions
• Aid in integration of new technologies into manufacturing operations
• Process Optimization & Operational Excellence
• Partner with Manufacturing to support safe, efficient, and reliable plant performance
• Identify and implement improvements in process robustness, product quality, and plant performance
• Support activities related to operational excellence and cost reduction
• Drive or participate in continuous improvement initiatives focused on yield and throughput, cycle time reduction, and cost and efficiency improvements
• Compliance & Documentation
• Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards
• Support campaign preparation, execution, and post-campaign review activities
• Aid in regulatory and inspection readiness activities
• Ensure accurate documentation of process knowledge, investigations, and improvements

Qualifications

• Minimum of a degree in Chemical Engineering, Chemistry, or a related discipline
• Typically 2-5+ years' experience in API manufacturing, process development, or related pharmaceutical environment (PhD may offset experience)
• Exposure to API processing operations and scale-up
• Understanding of cGMP manufacturing and regulatory expectations
• Experience in one or more of: Process support or development, Technology transfer, Manufacturing operations

Key Skills

• Strong analytical and problem-solving capability
• Effective communication and collaboration across cross-functional teams
• Proactive, self-driven approach to continuous improvement