
Validation and Sterilization Professional
hace 21 horas
We are seeking a Validation and Sterilization Professional to support our corporate sterilization workstream. As a senior-level professional, you will be responsible for supporting 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 knowledge and experience in microbiological testing data interpretation, sterility assurance monitoring, and maintenance.
They should also possess experience in conducting microbial test method validations and managing projects independently, as well as a strong understanding of controlled environment monitoring, bacterial endotoxin test method validation and monitoring, bioburden test method validation and monitoring, ethylene oxide sterilization, radiation sterilization, and dose audit management.
A bachelor's degree in microbiology or a similar discipline is required, along with a minimum of 7 years of experience in regulated environments with knowledge in sterilization processes.
Suitable candidates will have experience working with applicable regulations and their interpretation within industry, as well as strong project management skills and proficiency in Microsoft Project.
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Project Validation Spec.
hace 1 día
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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Sterilization Process Expert
hace 1 día
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 1 día
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...
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Validation and Compliance Professional
hace 5 días
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoAs a Validation & Quality Engineer at Flexible & Integrated Technical Services, LLC, you will be an integral part of our team, contributing to the success of our clients in the Pharmaceutical, Medical Device, and Manufacturing industries. Key responsibilities include:Developing SOPs and ensuring compliance with regulatory guidelinesSupporting the execution...
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Computer System Validation Professional
hace 7 horas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoAbout UsWe are Flexible & Integrated Technical Services, Llc, a service provider company that stands out from the rest. We pride ourselves on treating our employees like family and providing them with a flexible and family-oriented work environment.Job DescriptionWe are seeking a skilled Computer System Validation Professional to join our team. As a key...
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Quality Assurance and Validation Lead
hace 21 horas
Añasco, Puerto Rico Labchems Corp. A tiempo completoJob RequirementsWe are seeking an experienced Quality Assurance and Validation Lead to join our team. The successful candidate will be responsible for ensuring the quality and integrity of our products and processes.About the RoleThe Quality Assurance and Validation Lead will be responsible for:Supporting the development and implementation of quality and...
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Senior Validation Engineer
hace 24 horas
Añasco, Puerto Rico Labchems Corp. A tiempo completo**About Us:**Labchems Corp. is a leading organization in the industry, committed to delivering high-quality products and services.We are seeking a skilled Senior Validation Engineer to join our team and contribute to our mission.This role involves supporting facilities and construction projects, mainly in Collagen areas, by participating in meetings and...
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Project Validation Specialist Iii
hace 1 día
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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Facilities Validation Engineer
hace 3 semanas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoFor Validation Engineering services in the Facilities area.WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering or related field and at least three (3) years of previous exposure to Validation activities within the regulated industry.Bilingual: (Spanish and English) Shift: Administrative & according to business needs Experience...
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Medical Device Validation Engineer
hace 1 día
Añasco, Puerto Rico Labchems Corp. A tiempo completoJob OverviewLabchems Corp. is seeking a highly skilled Medical Device Validation Engineer to support the European Union Medical Device Regulation (EU MDR) program.About the RoleThe successful candidate will participate in data gathering, gap assessments, remediation planning, and documentation generation and execution for EU MDR compliance.Key...
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Validation Assurance Specialist
hace 3 horas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoJob DescriptionWrite, execute and maintain validation protocols on a timely basis.Ensure thorough and complete execution of all protocols, meeting FDA requirements.Develop documentation of investigations and communicate findings to minimize chance of recurrence.This role requires strong technical skills in SOP development, validation documentation, GMP and...
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Process Validation Engineer
hace 2 semanas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoFor Validation services in the Engineering & Manufacturing areas. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and previous exposure to validation quality activities within the Pharmaceutical or Medical Devices industry. Bilingual, Spanish and English (good communication) Shift: Administrative & according to business...
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Project Validation Specialist Eu Mdr
hace 3 semanas
Añasco, Puerto Rico Labchems Corp. A tiempo completoThe position is to support the European Union Medical Device Regulation (EU MDR) program. The incumbent will be supporting 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...
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Validation & Quality Engineer
hace 5 días
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoFor Validation & Quality services in the Engineering & Manufacturing areas. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and previous exposure to validation and/or quality activities within the Pharmaceutical or Medical Devices industry. Bilingual, Spanish and English (good communication) Shift: Administrative & according...
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Data Validation Specialist
hace 7 horas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoWe are a Service Provider company different from the rest. Flexible & Integrated Technical Services, Llc prides ourselves in how we treat the most important piece of our company's puzzle: you**Job Summary:**This role will be responsible for ensuring timely and thorough execution of Computer System Validation protocols, meeting FDA requirements. You will...
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Validation Specialist for Medical Devices
hace 1 día
Añasco, Puerto Rico Labchems Corp. A tiempo completoLabchems Corp. seeks a highly skilled Validation Specialist to join our team in supporting the EU MDR program. As a key member of our team, you will be responsible for ensuring compliance with EU MDR regulations by conducting thorough gap assessments and developing comprehensive remediation plans. Your expertise in validation activities, project management,...
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Project Validation Specialist
hace 4 semanas
Añasco, Puerto Rico Kelly Science, Engineering, Technology & Telecom A tiempo completoThe position is to support the implementation of labeling / artwork changes on Duragen product family for CE and non-CE marked SKUs. The incumbent will be supporting the following activities to ensure conformance with global labeling SOP for Duragen products manufactured at Integra Añasco.• Data Gathering – Participate in the discovery and compilation...
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Sr. Manager, Corp. Program Development
hace 1 día
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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Collagen Manufacturing Quality Expert
hace 5 días
Añasco, Puerto Rico Kelly Science, Engineering, Technology & Telecom A tiempo completoAbout the Role: We are looking for a skilled Regulatory Compliance Professional to work with our Core Team on facilities and construction projects. This person will review and approve documentation, participate in meetings, and ensure compliance with regulatory requirements.Responsibilities:Develop and maintain technical documents, including validation...
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Manufacturing Engineer
hace 4 semanas
Añasco, Puerto Rico Eqval A tiempo completoEQVAL Consulting Group, Inc. is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ).We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective...