Commercialization and Validation Engineer

Job Description

- 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 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

- 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 designat

ion (capability and capacity) and program complexity process for new product launches in support of category

strategy and RFT commercialization

- Engaged in/ 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

3-5 relevant FDA validation experience, Solid experience as Manufacturing Process Engineer in FMCG manufacturing plant, Lean manufacturing, Exceptional leadership and influence skills, Great collaborator

Proficient in both Korean and English is essential