22 Empleos en Juana Díaz
Auto Service Technician-Gst, Juana Diaz-906
Publicado hace 16 días
Trabajo visto
Descripción Del Trabajo
Auto Service Technician (GST): Debe tener aptitudes mecánicas y es capaz de realizar servicios automotrices básicos, incluido el montaje y balanceo de neumáticos, reparaciones de neumáticos, cambios de aceite, inspecciones de vehículos y otros servicios menos técnicos, al tiempo que brinda una excelente experiencia al cliente
Favor enviar resume a: ***
Requisitos:
Requisitos - Licencia de conducir de PR vigente, pasión por la carrera como GST en la industria automotriz, ansioso por aprender, debe tener 18+ años de edad, diploma de escuela secundaria o equivalente requerido, disponibilidad para trabajar días, noches, días festivos y fines de semana según sea necesario, finalización exitosa de la verificación de antecedentes previa al empleo
Favor enviar resume a: ***
Validation Specialist
Publicado hace 3 días
Trabajo visto
Descripción Del Trabajo
CI/Process Specialist
Publicado hace 3 días
Trabajo visto
Descripción Del Trabajo
CI/Process Specialist responsible for developing the scope of work for different projects including but not limited to manufacturing areas. Work with functional areas to improve productivity, efficiency, and capacity. Provide engineering support to Lean Manufacturing activities.
Responsibilities:
Managing the execution of programs and/or projects consisting of single or multiple projects and/or programs.Measure project performance against cost baseline.Participates during the coordination of product and equipment transferred to the plant. Responsible for the identification, development and implementation of process improvements and best practices focused on improvements in Safety, Quality, Delivery and Cost.Provide engineering support to Lean Manufacturing activities. Apply Lean and Six Sigma techniques to day-to-day situations and look for improvements.RequirementsBachelors of Science in Engineering, preferable Industrial Engineer.Experience in the Medical Devices Industry. Manage specific programs/Projects such as Tulip or LMMSKILLS: Project ManagementProcess TechnologyCross functional collaborationProficient in WORD, Excel, MS Project. Working knowledge of Lean Six Sigma. Knowledge of GM, QSR or ISOValidation Engineer
Publicado hace 14 días
Trabajo visto
Descripción Del Trabajo
Technical Skills
IQ/OQ/PQ protocol development and execution FAT/SAT testing and documentation Validation Master Plan (VMP) creation MES/SCADA system qualification Injection molding and automated assembly validation Metrology equipment calibration and Gage R&R Traceability Matrix development Experience with KNEAT software (highly desirable)Regulatory Knowledge
FDA 21 CFR Part 820 EU MDR 2017/745 ISO 13485 & ISO 14971 GMP complianceCertifications
ISO 13485 Quality Management ISO 14971 Risk Management GMP Training Six Sigma (Green or Black Belt)Soft Skills
Strong documentation and report writing Cross-functional collaboration Ability to train personnel Analytical thinking and problem-solvingLocation: SouthEast, United States (Travel Required)Sr Aseptic Process Engineering Manager
Publicado hace 15 días
Trabajo visto
Descripción Del Trabajo
Technical SME
Serve as aseptic filling SME with command of typical sterile fill finish unit operations, which may include aseptic and T.S. bag filling, aseptic liquid/ lyo vials, aseptic syringes/ cartridges, T.S. LVP bottles, Compounding, CIP/SIP systems, washing equipment, autoclaves, isolators, clean utilities (i.e. PW, WFI, CS, PS). Provide feasibility analysis and technical guidance on the design, project management, commissioning and start-up of equipment and sterile fill finish facilities (both brownfield and greenfield). Develop and review project descriptions, plans, timelines, resources requirements, costs and other associated sterile fill finish project details. Develop and review manufacturing risk assessments related to equipment, process, quality, and manufacturability changes. Mentor others on effective technical problem solving and process control.Sustaining Technical Stewardship
Identifies technology/ supplier landscape and contributes to equipment design, install, and qualification. Technical review of site Standard Operating Procedures, requirements, specifications, regulatory filings, and/ or other controlled documents as needed. Tracks and trends relevant technical and business process metrics to ensure fill/finish platforms are performing optimally and efficiently. Contributes to key technology transfers, manufacturability investigations, technology adoption, and continuous improvement initiatives.New Platforms and Growth
Drives innovation in fill finish manufacturing equipment and techniques through partnerships with internal R&D engineering and external technology suppliers. Leads the implementation of strategic new fill finish platforms from feasibility to EPCM to verification and validation. Develops first-of-kind technology User Requirements.Relationship Management
Maintain strong partnerships with Pharma Operations, Manufacturing Strategy, R&D, Sterility Assurance, and EHSS. Ensure alignment with Integrated Supply Chain leadership priorities and strategies. Uses technical expertise to influence decision making to a non-technical audience Contribute to new technology platform governance actions. Manage other engineering design firms, equipment vendors, construction firms, and internal/external partners as required to complete projects. Requirements Bachelor’s degree in life sciences or engineering 7+ years of relevant experience in highly automated fill finish project execution. 10+ years of proven experience in cGMP manufacturing environment and familiarity with formulation, aseptic filling, and visual inspection of liquid and lyophilized injectable products in bags, vials, and syringes. Strong process control, competence, design thinking, and technical feasibility analysis. Bilingual (Spanish/English)(Write/Speak) Ability to drive deliverable completion/ results and work effectively. Ability to lead and manage change, be decisive and focused.Software Application Configuration Specialist
Publicado hace 17 días
Trabajo visto
Descripción Del Trabajo
Validation Specialist
Publicado hace 23 días
Trabajo visto
Descripción Del Trabajo
Validation Specialist with hands-on experience in executing validation and qualification activities across diverse areas, including:
Process
Packaging
Manufacturing
Laboratory
Computer System Validation (CSV)
Software
Facilities and Utilities
Site Acceptance Testing (SAT) & Factory Acceptance Testing (FAT)
Commissioning and Decommissioning of Systems and Equipment
Core Competencies:
Skilled in drafting protocols, technical reports, and validation documentation in alignment with regulatory and industry standards (e.g., FDA, GMP).
Proven ability to collaborate effectively with cross-functional teams—including Engineering, Quality, and Production—to ensure compliance, optimize processes, and support operational readiness.
Requirements Bachelor Degree in Science, or related fieldMinimum 5 years of experience in validations within a regulated industry.In-depth knowledge of GMP, FDA, and international standards.Hands-on experience in IQ/OQ/PQ, SAT/FAT, and commissioning.Ability to write clear and precise technical documentation.Excellent communication and teamwork skills.Bilingual (English/Spanish - understand, write and speak).Sé el primero en saberlo
Acerca de lo último Todos Empleos en Juana Díaz !