Job Description: Responsible for Under leadership from Senior Commercialization and Validation Engineer, responsible for delivering and leading the site based commercialization team through “Right First Time”, technical commercialization of new products and technologies within their segment of the portfolio ensuring world class quality, robust and repeatable process capability, regulatory compliance (validation and documentation), optimal margin, at exceptional speed. In partnership with manager, engage and collaborate with stakeholders from program brief to delivery to ensure robust and effective technical commercialization plans, risk analysis, remediation plans, and technical gate alignment. Job Responsibilities: Identify, document and investigate protocol deviations in conjunction with cross functional teams, as required to resolve and close out deviations. 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 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 Installation Qualification (IQ), Operation Qualification (OQ) protocols for equipment used in the manufacture of OTC drug product, and Process Performance Qualification protocols for revised and new products or processes 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. 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 Support manager in development and execution of robust, site based commercialization plans for new products and technologies 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 Engage / lead new equipment performance specification development to enable and ensure RFT commercialization and long term performance expectations are met Job Requirements: Specs & Exp - Pharma / FDA validation experience, Solid experience as Manufacturing Process Engineer in FMCG manufacturing plant, Lean manufacturing, Exceptional leadership and influence skills, Great collaborator Job Details: Company: Estée Lauder Vacancy Type: Full Time Job Location: Blaine, MN Application Deadline: N/A Apply Here vacancyoptions.com
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