Regulated Manufacturing Project Coordinator
hace 2 semanas
The role of this position is to provide support to the European Union Medical Device Regulation (EU MDR) program at Labchems Corp. The successful candidate will be responsible for participating in data gathering and compilation of required documentation, conducting gap assessments on manufacturing documentation, and performing remediation tasks.
Key Responsibilities:- Data Gathering: Participate in the discovery and compilation of necessary documentation to be evaluated.
- Gap Assessments: Assess all manufacturing documentation, including product device master records, process flow charts, incoming inspections, and validation plans.
- Remediation Plan: Perform tasks identified as part of the remediation plan, including validation documentation generation and execution.
A Bachelor's degree in Engineering or Science is required, along with a minimum of 7-10 years of experience in validation activities and/or project management in a regulated manufacturing environment. Experience with regulatory agency guidelines for medical device manufacturers is also essential. The ideal candidate should have advanced skills in Microsoft Project, excellent verbal and written communication skills, and the ability to develop technical documentation.
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Project Oversight Specialist
hace 3 días
Añasco, Puerto Rico Gvs Inc A tiempo completoJob Summary">The Senior Operations Coordinator will oversee the planning, execution, and completion of projects related to transferring manufacturing processes, technologies, or products between facilities or locations. This role requires strong project management skills, including experience in managing projects and/or programs of increasing complexity.
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Senior Project Coordinator
hace 1 semana
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoOur MissionWe provide top-notch quality talent to our Pharmaceutical, Medical Device and Manufacturing industry clients while focusing on our resources' well-being and treating them with care. Job DescriptionThe Project Manager will be responsible for managing all aspects of project(s): planning, implementation, monitoring, completion, and follow-up. This...
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Manufacturing Project Oversight
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Añasco, Puerto Rico Gvs Inc A tiempo completoJob SummaryWe are seeking a highly motivated and experienced Program Manager to join our team at Gvs Inc. As a Program Manager, you will be responsible for leading complex projects from initiation to closure, ensuring timely delivery, and meeting customer expectations.Main ResponsibilitiesDevelop and maintain project plans, timelines, and budgets.Collaborate...
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Manufacturing Engineer
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Añasco, Puerto Rico Labchems Corp. A tiempo completoThe Manufacturing Engineer II, Life Cycle Management (LCM) will work within Engineering group to support the design changes impacting operations, manufacturing, launch readiness and production stability requirements of existing products. Will also provide technical expertise and project leadership in the areas of medical device life cycle management,...
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Project Manager
hace 4 semanas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoFor Project Management services in the Facilities area.WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Life Sciences, Engineering, or related field and at least five (5) years of previous exposure to Project Management activities within the regulated industry.Bilingual: (Spanish and English) Shift: Administrative & according to business...
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Senior Operations Coordinator
hace 3 días
Añasco, Puerto Rico Gvs Inc A tiempo completoKey Responsibilities">• Oversees the planning, execution, and completion of projects related to transferring manufacturing processes, technologies, or products between facilities or locations.• Manages projects and/or programs of increasing complexity, ensuring timely and within-budget delivery. • Develops and implements project plans, resource...
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Manufacturing Production Specialist
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Añasco, Puerto Rico Labchems Corp. A tiempo completoJob Description:The Manufacturing Engineer II, Life Cycle Management (LCM) will support the design changes impacting operations, manufacturing, launch readiness and production stability requirements of existing products within Labchems Corp.'s Engineering group.This role will provide technical expertise and project leadership in areas such as medical device...
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Project Manager Lead
hace 1 semana
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoAbout UsFlexible & Integrated Technical Services, LLC is a service provider company that integrates Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well). We pride ourselves in how we treat our resources with care and focus on their well-being while providing top-notch quality talent to...
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Project Validation Specialist
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Añasco, Puerto Rico Labchems Corp. A tiempo completoAt Labchems Corp., we are seeking a highly skilled Project Validation Specialist to support the efficient and timely completion of projects related to sterilization areas. This includes new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements.This role requires a...
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Project Validation Spec.
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Añasco, Puerto Rico Labchems Corp. A tiempo completoSupport CORPORATE STERILIZATION WORKSTREAM for efficient and timely completion of project related to sterilization area including, new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements, among others. Interprets microbiological testing data, monitors, and maintains...
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Head of Project Implementation and Coordination
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Añasco, Puerto Rico Labchems Corp. A tiempo completoJob Description">Labchems Corp. is looking for an accomplished Program Manager to oversee the transfer of manufacturing processes, technologies, or products between facilities or locations.">About This Position">This senior-level role involves overseeing project planning and coordination, stakeholder and risk management, process optimization, documentation...
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Program Management Lead
hace 3 días
Añasco, Puerto Rico Gvs Inc A tiempo completoAbout Gvs Inc">Gvs Inc is a leading provider of project management services, with a focus on transferring manufacturing processes, technologies, or products between facilities or locations.
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Medical Device Validation Expert
hace 3 días
Añasco, Puerto Rico Labchems Corp. A tiempo completoJob Description:The position is a critical support role for the Labchems Corp. EU MDR program. The successful candidate will be responsible for supporting key activities, including data gathering, gap assessments, remediation planning, and validation execution.Key Responsibilities:Data Gathering: Participate in the discovery and compilation of required...
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Project Validation Specialist Iii
hace 2 semanas
Añasco, Puerto Rico Labchems Corp. A tiempo completoSupport the European Union Medical Device Regulation (EU MDR) program with the following activities: Data Gathering–Participate in the discovery and compilation of required documentation to be evaluated. Gap Assessments–Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production...
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Sr. Manager, Corp. Program Development
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Añasco, Puerto Rico Labchems Corp. A tiempo completoOversees planning, execution, and completion of projects for transferring manufacturing processes, technologies, or products between facilities or locations. Project Planning and Coordination, Stakeholder and Risk Management, Process Optimization, Documentation and Reporting. Coordinates teams across different geographies, ensuring effective communication...
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Program Management Director
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Añasco, Puerto Rico Gvs Inc A tiempo completoJob DescriptionWe are seeking a highly skilled Program Management Professional to oversee the planning, execution, and completion of projects related to transferring manufacturing processes, technologies, or products between facilities or locations.Key ResponsibilitiesLead complex projects with increasing complexity and scope.Maintain strong relationships...
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Strategic Program Lead
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Añasco, Puerto Rico Gvs Inc A tiempo completoJob OverviewWe are seeking an experienced Strategic Program Lead to oversee the planning, execution, and completion of projects related to transferring manufacturing processes, technologies, or products between facilities or locations.Key ResponsibilitiesDevelop and implement project plans, ensuring timely and within-budget deliveryLead cross-functional...
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Program Oversight Director
hace 7 días
Añasco, Puerto Rico Gvs Inc A tiempo completoProgram Management RoleWe are seeking a highly skilled Program Manager to join our team and lead the development and implementation of projects related to transferring manufacturing processes, technologies, or products between facilities or locations.Main ResponsibilitiesDevelop and execute project plans, ensuring timely and cost-effective deliveryBuild and...
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Sterilization Process Expert
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Añasco, Puerto Rico Labchems Corp. A tiempo completoLabchems Corp. is looking for a Sterilization Process Expert to join our team. As a key member of our sterilization workstream, you will be responsible for ensuring the efficient and timely completion of project-related tasks.Key responsibilities include interpreting microbiological testing data, monitoring and maintaining sterility assurance, and conducting...
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Senior Validation Specialist
hace 2 semanas
Añasco, Puerto Rico Labchems Corp. A tiempo completoAt Labchems Corp., we are seeking a Senior Validation Specialist to support the efficient completion of project-related tasks for the sterilization area. This includes new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements.The ideal candidate will have advanced...