Sr. Process Development Engineer

Evergen•Alachua, FL

3h•Onsite

About The Position

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM [https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Flnkd.in%2FeMSfVJkM%25C2%25A0&data=05%7C02%7Cmbryant%40rtix.com%7C30e73d12e27241f10e1d08dd34b44951%7Ca2634573845f4a629ae39abc3005b6d4%7C0%7C0%7C638724671112434886%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=sg%2BZ8%2FBy27OhYFADAZd0qteD60A2y6K2NMxFCndUUa0%3D&reserved=0]; Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values: Accountable: We own our actions and decisions. Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth. Growth Mindset: We embrace challenges as opportunities for continuous learning. Customer-Centric: We prioritize customers at every touch point. Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated. At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success. Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.

Requirements

Bachelor of Science Degree in relevant area
6+ years of relevant medical device, pharmaceutical, or other regulated industry experience
Excellent verbal and written communication
Project Management
Microsoft Office Suite
Laboratory Testing
Design software
Move or lift objects up to 25 pounds
Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
Onsite: Office environment with assigned workstation
Remote positions only: Home office environment with minimum distractions

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.