POSITION PURPOSE

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.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

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.

PERFORMANCE MEASUREMENTS

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.

EDUCATION/CERTIFICATION

BS in Chemical, Mechanical, Industrial, or related Engineering field required; MS preferred.

EXPERIENCE REQUIRED

4-8+ years in process development, new product introduction, scale-up, or commercialization within consumer products, medical device, pharmaceutical, or related manufacturing; experience with liquid filling, nonwoven converting, or packaging operations preferred.

SKILLS/ABILITIES

Strong cross-functional collaboration and communication skills. Hands-on experience with DOE, SPC, PFMEA, and control plan development. Demonstrated success in leading factory trials and product launches. Lean/Six Sigma certification preferred. Ability to manage multiple priorities with urgency and accountability.

WORKING CONDITIONS

Office, laboratory, and manufacturing floor environments; pilot plant environments as that capability is established. Requires occasional lifting (