Process Validation Engineer

Direct Contingent WorkerDirect Contingent Worker Posting Title: Direct Contingent WorkerDivision: Country USA Work Location: Houston, TXFunctional Area: Technical OperationsJob Type: Full Time Employment Type: ContractJob Description:Development of new injection molding processes using scientific molding principles.Lead complete IQ/OQ/PQ validation activities of both thermoplastic and silicone injection molds working with all stakeholders including Engineering, Production and Quality.Troubleshoot molding processes to mitigate production defects and or improve efficiency.Participate in design reviews of new tooling and equipment working with both external and internal injection mold makers.Lead technology improvements that advance our molding processes for new and existing products.Prepare complete and accurate records/documentation of assigned project activities per the established Quality System and Validation Guidelines.Participate in regular project meetings, publishes timely project updates, and follows-up continuously on all open critical path items.Generate and maintain documentation for applicable internal processes and procedures, inspection criteria, Bill of Materials, Validation Protocols/Reports and other manufacturing and quality records.Identify, initiate and implement technology improvements, which increase productivity and reduce scrap/reject rates through effective training of production personnel and process enhancements.Maintain and improve product quality by performing and documenting robust root cause investigations and implementing effective corrective and preventive actions.Develop and leverage product knowledge to ensure Critical Quality Attributes (CQAs) are consistently met.Minimum Education Requirements:Bachelor degree in Engineering or equivalent years of directly related experience (or high school +8yrs; Assoc. +4 yrs; Scientific Molding Certifications (master molder) +2yrs)Direct Contingent Worker:Preferred: Bachelor degree in Plastics Engineering or Scientific Molding Certification completion.Minimum Experience Requirements:Minimum: 2 years experience in high volume molding and manufacturing environmentPreferred: 2 years experience in medical device manufacturing or other highly regulated industryWorking knowledge of Validation processes (IQ/OQ/PQ)Technical expertise in injection molding of thermoplastics related to Design for Manufacturability of molds, processing of thermoplastics, robotics, automation and hot runner systemComprehensive knowledge and thorough understanding of troubleshooting techniques for the injection molding process, machine, robot and auxiliaries.Experience with advanced processing techniques (eDart), robot programming, hot runner molds, tooling issue diagnostics, molding machine diagnostics, central material handling systems and color blending.Processing knowledge of Polycarbonate, Acrylic, ABS, Polysulfone, and various commodity resinsFamiliar with SPC methodologies and the scientific molding process.Data driven, disciplined, objective and detail oriented.Ability to read and interpret part and mold drawingsAbility to work with minimal supervision and/or guidanceFamiliarity with statistical problem solving techniquesExcellent organization and communication skills.Knowledge of FDA regulations and other international compliance standardsCompetency in the following software: MS Project, Excel, Word, PowerPointEEO Statement: Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.