Senior Validation Specialist
hace 6 días
At 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 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.
This role requires 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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Senior Validation Engineer
hace 5 días
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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Data Validation Specialist
hace 5 días
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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Project Validation Spec.
hace 6 días
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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Validation Specialist for Medical Devices
hace 5 días
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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Validation Assurance Specialist
hace 4 días
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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Project Validation Specialist Iii
hace 6 días
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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Validation and Sterilization Professional
hace 5 días
Añasco, Puerto Rico Labchems Corp. A tiempo completoWe 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...
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Project Validation Specialist Eu Mdr
hace 4 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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Quality Assurance Specialist
hace 6 días
Añasco, Puerto Rico Labchems Corp. A tiempo completo**Job Summary:**Labchems Corp. seeks a highly skilled Quality Assurance Specialist to support our facilities and construction projects in Collagen areas.The ideal candidate will be part of the Core Team, participating in meetings and reviewing/approving all documentation required for project success.This role involves developing technical documentation,...
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EU MDR Compliance Specialist III
hace 5 días
Añasco, Puerto Rico Labchems Corp. A tiempo completoCompany OverviewLabchems Corp. is a leading manufacturer of high-quality laboratory chemicals and equipment. Our commitment to innovation and customer satisfaction has earned us a reputation as a trusted partner in the scientific community.Job DescriptionWe are seeking a highly skilled EU MDR Compliance Specialist III to join our team. The successful...
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Quality Assurance Specialist
hace 1 semana
Añasco, Puerto Rico Labchems Corp. A tiempo completoJob Overview">At Labchems Corp., we are seeking a highly skilled Quality Assurance Specialist to support our facilities and construction projects. As a key member of the Core Team, you will participate in meetings and review/approve all documentation required for facility projects. Your primary responsibilities include developing technical documentation,...
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EU MDR Compliance Specialist
hace 5 días
Añasco, Puerto Rico Labchems Corp. A tiempo completoWe are seeking a highly experienced EU MDR Compliance Specialist to join our team at Labchems Corp. As a critical member of our compliance team, you will be responsible for ensuring that our company remains compliant with EU MDR regulations. Your expertise in validation activities, project management, and technical documentation will be essential in...
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Csv Specialist
hace 3 semanas
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoFor Computer System Validation and Software services in the Manufacturing area.WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Life Sciences or Engineering and previous exposure in Computer System Validation activities within the regulated industry.Bilingual, Spanish, and English.Shift: Administrative & according to business needs ...
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Production Process Specialist
hace 6 días
Añasco, Puerto Rico Labchems Corp. A tiempo completoJob Description:Labchems Corp. is seeking a highly skilled Production Process Specialist - Life Cycle Management to join our Engineering team.About the Role:This position will work closely with cross-functional teams to support design changes impacting operations, manufacturing, launch readiness, and production stability requirements of existing products.The...
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Technical Specialist for Life Sciences
hace 4 días
Añasco, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completoAbout Our CompanyFITS is a unique service provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island and in the US. We value our resources' well-being and provide top-notch quality talent to our Pharmaceutical, Medical Device, and Manufacturing industry clients.Job OpportunityWe...