Commercialization and Validation Engineer
8.15 - 4.30pm Monday - Friday
Travel: Yes, 10 % of the Time
My client is currently recruiting for a Commercialization and Validation Engineer within the Engineering Department to join an experienced and committed team
The successful candidate will be under leadership from the Commercialization and Validation Engineering Lead, 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 a collaborative 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.
The key responsibilities include:
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 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.
Preferred Area of Degree: Mechanical / Package / Chemical Engineering.
Specifications and Experience: Preferred minimum of 5 years experience.
Pharma / FDA validation experience, Solid experience as Manufacturing Process Engineer in FMCG manufacturing plant, Lean manufacturing.
Exceptional leadership and influence skills.
Great team collaborator.
Experience in managing other team members would be desirable