New Products Launch Engineer

Kempen
Solliciteer nu

We are looking for a New Products Launch Engineer with experience in Pharma / FDA validation and Lean Manufacturing for our client in the cosmetics industry in the region of Kempen.

Your responsibilities as a New Products Launch Engineer

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 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.

  • 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.
  • 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.
  • Drive new product and technology commercialization performance versus agreed process KPIs; manage team performance and measure team's ROI.

What we expect from a new products launch engineer

  • Education - Master in Mechanical / Package / Chemical Engineering.
  • Experience - Minimum 5 years of experience, Pharma / FDA validation experience, experience as Manufacturing Process Engineer in FMCG manufacturing plant, Lean manufacturing.
  • Skills - Leadership and influence skills, great collaborator.

Our client offers

A full-time employment in which you have to travel (5%), rewarded with a gross salary and other benefits as a hospitalization insurance (family included), group insurance, meal vouchers, shop discount for company products, bicycle lease and allowance, 20 days of vacation and 12 ADV days.

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