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Evergen · 11 hours ago

Sr. Process Development Engineer

Alachua, FL, US

Full-time

Onsite

Senior Level

$95K/yr - $125K/yr

6+ years exp

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. The Sr. Process Development Engineer will lead the strategic design and execution of experimentation to drive process characterization, optimization, and troubleshooting, ensuring the integration of new products into production.

Health CareIndustrial ManufacturingMedical DeviceProduct Design

Responsibilities

Leads the strategic design and execution of experimentation (e.g., DOE) to drive process characterization, optimization and troubleshooting, bridging the technical gap from lab to pilot to commercial manufacturing

Leverage statistical methods to analyze data and formulate technical conclusions, defining process control strategies or monitoring plans, and optimization of process yields or minimization of sources of variation

Apply deep subject matter expertise in relevant product and process technologies to lead the selection, design, development, optimization, and validation of equipment and processes throughout the New Product Development (NPD) lifecycle

Champion the application of Design for Six Sigma (DFSS) and DMAIC methodologies during process characterization, optimization, and troubleshooting of processes

Lead the application of Lean methodologies to systematically identify and eliminate process inefficiencies and non-value-added activities, ensuring the development of efficient, cost-effective equipment and manufacturing systems

Champion the integration of Human Factors/Usability Engineering and Safety by Design principles into equipment development, ensuring processes are ergonomically sound, intuitive for operators, and compliant with safety standards to minimize use error and injury risks

Collaborate with Design Transfer, R&D, and Quality stakeholders to establish Critical Process Parameters (CPPs) derived from Critical Quality Attributes (CQAs), leading characterization studies that define the process bounds and enable successful validation

Establish the scientific rationale defining validation scope and risk mitigation strategies, ensuring that process characterization data is effectively translated into FMEA and validation inputs

Lead the authoring and execution of validation protocols (IQ/OQ/PQ/PV), analyzing data to generate comprehensive validation reports and packages that demonstrate process capability and compliance

Develop comprehensive training strategies and materials to ensure operational readiness for new equipment and processes transferred into production

Lead the technical transfer of new products and processes into production, partnering with Design Transfer, R&D, Manufacturing, and Quality stakeholders to ensure seamless integration, process robustness, and operational readiness

Actively scouts and evaluates emerging manufacturing technologies and state-of-the-art industry practices, driving the adoption of innovative solutions to optimize project execution and process capabilities

Drive the generation of novel processing methods and unique equipment adaptations, actively contributing to the expansion and protection of the corporate Intellectual Property (IP) portfolio

Other duties as assigned