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Leads complex manufacturing engineering projects, line studies, and qualification and validation activities. Develops validation strategies, protocols, reports, sampling plans, and data analyses independently. Provides guidance on validation deviations and complex data interpretation while leading root cause analyses for significant manufacturing events using DMAIC and A3 methodologies.

Provides administrative and accounting support, including financial data entry, invoicing, payment processing, billing, collections, payroll data entry, reconciliations, month-end support, reporting, and record maintenance. Researches invoice discrepancies, organizes audit documentation, responds to routine billing inquiries, and protects confidential information. Requires accuracy, organization, professional English and Spanish communication, and familiarity with QuickBooks and Excel.

Supports SAP implementation, validation, testing, go-live, hypercare, and user adoption within a regulated medical device manufacturing environment. Provides SAP module expertise, troubleshoots transactions and workflows, develops compliant documentation and training, coordinates with IT and SAP partners, and ensures alignment with FDA, ISO 13485, data integrity, and audit requirements. Identifies process gaps and supports post-go-live optimization.

Leads and owns complex manufacturing engineering tasks within a technical discipline. Responsibilities include setting direction, identifying and resolving issues, developing creative solutions, coordinating with peers, and supporting verification and validation activities. The role requires knowledge of manufacturing operations, equipment validation, documentation, process implementation, and business objectives.

Manage full-cycle recruitment for multiple client projects, including job postings, candidate sourcing, resume evaluation, phone screenings, interview coordination, ATS recordkeeping, talent pipeline development, and candidate engagement. Collaborate with clients, account managers, and project teams to meet hiring objectives, maintain recruitment metrics, and deliver qualified technical and regulated-industry candidates.

Lead complex, cross-functional projects from business case development through execution and product launch. Manage project schedules, resources, risks, budgets, governance, change control, project controls, and capital projects. Oversee New Product Introduction, technology transfer, process development, lifecycle management, commercialization, and process validation activities. The role requires extensive project management experience, bilingual English and Spanish fluency, and the ability to lead projects in a dynamic environment.

Leads strategic and complex New Product Introduction programs from planning through commercialization and operational readiness. Develops project strategies, governs cross-functional execution, aligns stakeholders, manages business risks, and mentors project teams. Coordinates priorities, change control, communication, presentations, and project documentation in a matrixed environment. Requires bilingual English and Spanish communication, project management experience, Ariba expertise, strong Microsoft Office skills, and substantial experience based on education level.

Senior Engineer supporting manufacturing processes and products through process improvement, validation, product transfers, change controls, new product introductions, and capital projects. The role analyzes and resolves manufacturing issues, coordinates equipment and process validations, prepares regulatory documentation, supports FDA interactions, and provides technical assistance to manufacturing teams. It also requires statistical analysis, cross-functional coordination, supplier interaction, and bilingual Spanish-English communication.

Leads complex, cross-functional New Product Introduction programs from strategy through commercialization and operational readiness. Manages schedules, risks, stakeholder alignment, change control, scope, quality, costs, and timelines across multiple departments. Provides project team leadership, mentorship, and strategic direction while coordinating department operations and serving as a liaison between project teams and stakeholders. Requires bilingual English and Spanish communication skills and proficiency with sourcing, enterprise, project management, and office productivity tools.

Process Engineer supporting pharmaceutical and medical device manufacturing operations. Responsibilities include validation lifecycle activities, root cause analysis, QN and CAPA investigations and closures, and support for manual and automated production systems. The role requires a bachelor’s degree in engineering, medical device experience, bilingual English and Spanish skills, and flexibility to support 24/7 operations, including shifts, weekends, and holidays, in Texas.