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 ensuring world class quality, robust and repeatable process capability, regulatory compliance (validation and documentation), optimal margin, at exceptional speed. 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.
Key Roles and Responsibilities
Lead site technical commercialization team in collaboration 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.
Lead 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 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
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
Represent 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
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
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
Support SC Category strategy development and strategy execution in support of RFT commercialization of new products and technologies
Lead site in feasibility / feasibility cost assessments for new products
Lead site in technical commercialization process improvement activity across categories and platforms in support of NPL continuous improvement
Drive new product and technology commercialization performance versus agreed process KPIs; manage team performance and measure team's ROI
QUALIFICATIONS
Additional Job Specifications & Experience / KPIs
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
KPIs – RFT, COGs/Margin optimization, Speed to Realization
We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact USApplicantAccommodations@Estee.com.
The Estée Lauder Companies (ELC) is the global leader in prestige beauty. ELC is the only company focused solely on prestige makeup, skin care, fragrance and hair care with a diverse portfolio of 25+ brands sold in approximately 150 countries and territories. Infused throughout the organization is a passion for creativity and innovation — a desire to push the boundaries and invent the unexpected — as we continue the bold work of the company’s founder Estée Lauder.