Apex Systems, the nation’s 2nd largest Information Technology and Engineering staffing firm, has a Direct Hire opportunity for a Director, Commercialization and Validation Engineering to work for a top company in the Melville, NY area.
Director, Commercialization and Validation Engineer
Direct Hire (relocation package available)
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.
- 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
- Drive new product and technology commercialization performance versus agreed process KPIs; manage team performance and measure team's ROI
- 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 new equipment performance specification development to enable and ensure RFT commercialization and long term performance expectations are met
- 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
- 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
- Manage the prioritization, project/portfolio resource allocation
- Responsible for identifying and deploying best practice, ensuring compliance with policies & procedures
- Represent the site/campus on the global commercialization leadership team and the Category leadership team, and sit on the site leadership team
- Bachelors in Mechanical, Packaging, or Chemical Engineering preferred
- 8+ years’ experience as Manufacturing Process Engineer in FMCG/CPG manufacturing plant,
- Pharma / FDA validation experience, Solid experience
- KPIs – RFT, COGs/Margin optimization, Speed to Realization
- Lean manufacturing, Exceptional leadership and influence skills preferred
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178