Commercialization and Validation Engineer

hace 2 semanas

Panama Emonics, Llc A tiempo completo

Job Description: - Technical/Functional Skills - " Collaborate with other technical development functions through RFT, technical commercialization of new products and technologies ensuring world class quality, robust and repeatable process capability, regulatory compliance (validation/documentation), optimal margin, at exceptional speed. " Support manager in development and execution of robust, site-based commercialization plans for new products and technologies. " Develop/revise and execute validation procedures and protocols as related to equipment, utilities, and processes to ensure that products are manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices. To include (PPQ) to support the manufacture of OTC drug product - Process Performance Qualification protocols for revised and new products or processes. " Identify, document and investigate protocol deviations in conjunction with cross functional teams, as required to resolve and close out deviations. " Lead execution gates 5 and 6 pFMEA / risk assessment and remediation plan development and execution for key new product and technology initiatives, collaborating with cross functional technical teams to ensure risk profile is clearly communicated and remediation plans with clear accountabilities are developed and executed. " As needed, represent manager and site based technical commercialization team in technical gate reviews ensuring technical issues are identified and resolved to enable gate progression, delivering expected and aligned commercialization outcomes. " In partnership with manager and team, engage / lead commercialization team and stakeholders in site enabled value engineering, champion opportunities to optimize quality, leverage and evolve automation, and collaborate to optimize design, process, cost and performance of new product and technology elements. " In partnership with manager and team, represent site commercialization team in manufacturing location designation (capability and capacity) and program complexity process for new product launches in support of category strategy and RFT commercialization. " Engage / lead new equipment performance specification development to enable and ensure RFT commercialization and long-term performance expectations are met. " Lead site in feasibility / feasibility cost assessments for new products within their segment of the product portfolio. " Participate in technical commercialization process improvement activity across categories and platforms in support of NPL continuous improvement. " Drive new product and technology commercialization performance within their segment of the product portfolio versus agreed process KPIs; manage team performance and measure team's ROI. Travel 10 to 20 % Qualification: Degree: Mechanical / Chemical Eng

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