Process Engineer, R&D

The Process Engineer, R&D leads process development, scale-up, and commercialization of new and redesigned products from bench through scale-up trials and into full-scale manufacturing, serving as the critical bridge between R&D, Operations, and external partners to ensure first-time-right launches. This role designs and executes bench and scale-up trials on production and partner assets, generates data to inform scale-up decisions, and establishes robust process windows for commercialization.

As PDI builds internal pilot-scale capability, this role will define its requirements and lead pilot trials as a growing focus of the position. It also supports Procurement and Supply Chain in identifying, technically evaluating, and onboarding third-party manufacturers (CMOs/contract fillers/packagers), confirming they can meet PDI’s quality, regulatory, and cost standards. Through strong collaboration with internal teams and external partners, this position ensures product launches are delivered safely, compliantly, on-time, and on-cost, while driving continuous improvement in process capability and efficiency.

• Translate product requirements and critical-to-quality attributes into scalable process parameters and control plans.
• Plan and execute bench, scale-up, and line validation trials, including DOE studies, to establish robust process windows and readiness for launch.
• Lead technology transfer from R&D to Manufacturing, including SOPs, equipment set-up, and operator training.
• Define and recommend the full manufacturing process — equipment, materials, process parameters, and controls — and issue formal, data-backed recommendations to Operations Engineering so scale-up, manufacturing line/asset selection, and CMO qualification decisions are validated before launch rather than resolved on the production floor.
• Partner with Packaging, Formulation, Quality, Regulatory, Supply Chain, and Operations to deliver first-time-right product launches.
• Partner with Procurement and Supply Chain to identify, evaluate, and qualify third-party manufacturers (CMOs, contract fillers/packagers), including technical capability assessments, pilot production readiness, and alignment with PDI’s quality and regulatory standards.
• Assess, specify, and qualify new equipment, tooling, and raw materials required for scale-up and commercialization, ensuring alignment with manufacturing capability, automation opportunities, QMS, and EHS requirements.
• Lead PFMEA, DFM/DFR reviews, and process risk assessments, and own the DOE and process capability studies that drive first-pass yield, to ensure smooth commercialization and regulatory compliance.
• Track launch KPIs (e.g., yield, cycle time, scrap, OEE, COGS) and implement corrective actions as needed.
• Drive continuous improvement using Lean/Six Sigma tools to reduce cost and variability across processes.
• Maintain accurate, audit-ready technical documentation throughout the development and launch lifecycle.
• Champion safe work practices and ensure compliance with EHS requirements in laboratory and manufacturing environments, and in pilot plant environments as that capability is established.
• Participate in root cause investigations for process-related challenges.

• Bench-to-plant scaling accuracy within ±10% of target process parameters.
• First-pass yield ≥95% within 30 days of launch.
• Provide validated process documentation and controls to support Manufacturing in achieving minimal scrap during launch and production startup
• OEE and throughput meet or exceed business case assumptions.
• On-time, in-full delivery of process documentation, SOPs, and control plans.
• Positive cross-functional feedback on collaboration and technical leadership.