Process Development Engineer

Process Development Engineer

We are seeking a detail-oriented and proactive Process Development Engineer to join our team. This role focuses on translating new laboratory-scale chemical processes into safe, executable manufacturing instructions for scale-up within a small molecule API production facility. The ideal candidate will spearhead kilo lab or plant processing, coordinate cross-functional production support, and execute technical troubleshooting directly on the production floor.

Key Responsibilities

New Process Scale-Up & Execution

• Process Translation & Instructions: Interact closely with chemists to understand new chemical processes, translate them into executable instructions (batch records), and guide operators through initial production.
• Kilo lab or Plant Scaling: Learn and scale up production processes from the laboratory to the kilo lab or plant infrastructure, troubleshooting and adapting techniques when small molecule processes do not scale as expected.
• Operational Supervision: Oversee the execution of processing, participate on the production floor as appropriate, and review executed batch records to ensure technical compliance.

Documentation & Safety Compliance

• Supporting Documentation: Author, review, and organize necessary processing documentation, including batch records, deviations, material specifications, hazard sheets, air emissions data, and processing reports.
• Safety & Risk Mitigation: Conduct process safety meetings, develop safety review packages, and ensure all scaling activities strictly adhere to plant safety protocols.
• Cross-Functional Collaboration: Interact closely with Chemistry, Quality, and Operations departments throughout the production lifecycle, while managing external interactions with vendors and contractors.

Technical Troubleshooting & Client Interaction

• Process Troubleshooting: Apply development troubleshooting and problem-solving skills to identify, investigate, and resolve process deviations or scaling anomalies directly on the shop floor.
• Client Status Updates: Act as a key technical point of contact for clients, hosting regular project status updates, delivering tech transfer summaries, and communicating technical milestone progressions clearly.
• Infrastructure Support: Provide day-to-day chemical engineering support for the maintenance, optimization, and upkeep of pilot plant equipment and infrastructure.

Required Skills & Qualifications

• Education: B.S. or M.S in Chemical Engineering. B.S. or M.S. in Chemistry with relevant plant experience will also be considered.
• Experience: Two or more years of relevant chemical processing or plant experience is preferred. Experience operating within a regulated cGMP environment is a distinct plus.
• Technical Competencies: Strong foundational knowledge of chemical process scale-up, mass/energy balances, process safety management, and technical document authoring.
• Collaborative Nature: Exhibits effective time management and a strong multi-tasking mindset to self-manage assigned tasks, drive projects to completion, and work effectively in a multi-disciplinary team environment.