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 (<25 lbs.), standing for trials, and use of PPE.
- Limited travel (<15%) to manufacturing sites, suppliers, or external partners.
Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored visa sponsorship.
SALARY RANGE
- $105,000 - $120,000, plus bonus
PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes:
- Medical & prescription drug coverage
- Dental / Vision plan
- 401(k) savings plan with company match
- Basic and supplemental life insurance
- Flexible Spending Accounts (FSAs)
- Short- and long-term disability benefits
- Health Advocacy Program / Employee Assistance Program (EAP)
Many other voluntary benefit plans and perks such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance, tuition assistance, referral bonus program, paid parental leave, a health club rebate program and more
At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options
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