Commercialization and Validation Engineer
3+ months ago• Seoul, South Korea
- 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
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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
Qualifications
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
Job: Inventory Management and Planning - Supply Chain
Primary Location: Asia Pacific-KR-11-
Job Type: Standard
Schedule: Full-time
Shift: 1st (Day) Shift
Job Number: 247095
Client-provided location(s): Seoul, South Korea
Job ID: ELC_Beauty-247095
Employment Type: FULL_TIME
Posted: 2024-05-31T11:40:50
Perks and Benefits
Health and Wellness
Parental Benefits
Work Flexibility
Office Life and Perks
Vacation and Time Off
Financial and Retirement
Professional Development
Diversity and Inclusion