Validation Specialist
6 days ago
- Perform commissioning, qualification, validation, and maintenance activities within the facility.
- Oversee multiple CQV projects, providing updates and coordinating with internal teams and external vendors.
- Lead and support quality investigations, CAPAs, and process improvements to enhance compliance and efficiency.
- Develop and implement remediation efforts and CAPA plans to resolve issues.
- Author and manage CQV protocols, summary reports, change controls, SOPs, and technical documentation.
- Contribute to risk assessments, FMEAs, project planning, master plans, and annual product reviews.
- Collaborate closely with Quality, Manufacturing Operations, Facilities & Engineering, Supply Chain, and other teams to drive success.
- Bachelor's degree in Science, Engineering, or a related technical field.
- At least 2 years of relevant experience, preferably in an aseptic manufacturing or cell therapy environment.
- Strong knowledge of cGMP regulations, FDA/EU guidelines, and Good Tissue Practices (cGTP).
- Expertise in CQV processes, process optimization, and regulatory compliance.
- Experience working with batch records, SOPs, CQV protocols, and technical documentation.
- Excellent analytical, organizational, and communication skills.
- Familiarity with TrackWise, Comet, CMMS, Veeva, Maximo, Kneat, Kay, and AVS/Validator is a plus.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
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Validation Specialist
6 days ago
Jersey City, New Jersey, United States Piper Companies Full timePiper Companies, a leading pharmaceutical company, is seeking an experienced Validation Specialist to join its team in Raritan, NJ. As a key member of the validation team, you will be responsible for providing technical expertise for commissioning, qualification, and validation maintenance processes while ensuring compliance with GMP and FDA standards.The...
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Validation Specialist
6 days ago
Jersey City, New Jersey, United States Hays Recruitment Full timeHays Investor Work for Hays About Us Find Us For Job Seekers For Organizations Australia Austria Belgium Brazil Canada Chile China Colombia Czech Republic Denmark France Germany Hong Kong SAR Hungary Italy Japan Luxembourg Malaysia Mexico Netherlands New Zealand Poland Portugal Romania Singapore Spain Sweden Switzerland Thailand UAE United Kingdom United...
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Validation Specialist
19 hours ago
Jersey City, New Jersey, United States Hays Recruitment Full timeHays Investor Work for Hays About Us Find Us For Job Seekers For Organizations Australia Austria Belgium Brazil Canada Chile China Colombia Czech Republic Denmark France Germany Hong Kong SAR Hungary Italy Japan Luxembourg Malaysia Mexico Netherlands New Zealand Poland Portugal Romania Singapore Spain Sweden Switzerland Thailand UAE United Kingdom United...
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Validation Specialist Lead
6 days ago
Jersey City, New Jersey, United States Hays Recruitment Full timeJob OverviewThe role of a Validation Specialist at Hays Recruitment involves ensuring the accuracy and reliability of computer systems in regulated industries. This position requires applying FDA, MHRA, and other global health authority regulations to the development of these systems. A strong understanding of industry best practices and SOPs is necessary...
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Test & Validation Specialist
2 days ago
Jersey City, New Jersey, United States Oshkosh Corporation Full timeOshkosh Corporation is seeking a highly skilled Test & Validation Specialist to join our team. As a key member of our engineering team, you will be responsible for designing and developing test fixtures and procedures to validate product performance.Responsibilities include but are not limited to:Designing and developing test fixtures and proceduresWorking...
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Validation Specialist
12 hours ago
Jersey City, New Jersey, United States Hays Recruitment Full timeAbout UsHays Recruitment is a leading recruitment agency specializing in temporary and permanent placement of professionals in various industries. We are committed to building a thriving culture of diversity and inclusion that welcomes people from different backgrounds, perspectives, and experiences.In this Validation Specialist - Contract role, you will...
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Computer System Validation Specialist
5 days ago
Jersey City, New Jersey, United States Diverse Lynx Full timeJob DescriptionAs a Computer System Validation Specialist at Diverse Lynx LLC, you will be responsible for developing and executing validation protocols for computer systems to ensure compliance with regulatory requirements and industry standards. Your key tasks will include creating detailed validation documentation, conducting risk assessments, and...
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Computer System Validation Specialist
2 days ago
Jersey City, New Jersey, United States Diverse Lynx Full timeAt Diverse Lynx LLC, we are seeking a highly skilled Computer System Validation Specialist to join our team. In this critical role, you will play a key part in ensuring the accuracy and reliability of our computer systems.The ideal candidate will have experience in developing and executing validation protocols for computer systems, with a strong focus on...
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Product Validation Specialist
5 days ago
Jersey City, New Jersey, United States Unitek Technical Services Full timeOverview of the Position">We are seeking a skilled Product Validation Specialist to join our team at Unitek Technical Services. In this role, you will be responsible for ensuring the quality and integrity of aerospace products by conducting thorough source inspections.">Key Responsibilities">Performing product source inspections, including in-process, final,...
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Computer Systems Validator
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Jersey City, New Jersey, United States Hays Recruitment Full timeJob DescriptionWe are seeking a skilled Validation Specialist to join our team at Hays Recruitment. In this role, you will be responsible for ensuring the accuracy and reliability of computer systems in regulated industries. You will apply FDA, MHRA, and other global health authority regulations to the development of these systems. A strong understanding of...
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Validation and Compliance Manager
24 hours ago
Jersey City, New Jersey, United States Kasmo Global Full timeJob SummaryWe are seeking a highly skilled Validation Specialist to join our team. The ideal candidate will have a strong background in commissioning, qualification, validation, and maintenance activities within aseptic manufacturing or cell therapy environments.The successful candidate will oversee multiple CQV projects, providing updates and coordinating...
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Pharmaceuticals Validation Expert
5 days ago
Jersey City, New Jersey, United States Hays Recruitment Full timeRole SummaryThe Validation Specialist role at Hays Recruitment involves ensuring the accuracy and reliability of computer systems in regulated industries. This position requires a strong understanding of industry best practices and SOPs, as well as the ability to apply FDA, MHRA, and other global health authority regulations to the development of these...
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Senior Computer System Validation Specialist
6 days ago
Jersey City, New Jersey, United States EPM Scientific Full timeWe are seeking a highly skilled Senior Computer System Validation Specialist to join our client on a contract basis. This role is crucial for ensuring the validation and compliance of computerized systems in a regulated, GxP-compliant environment, contributing to the production of innovative oncology treatments.Key Responsibilities:Lead and Execute CSV...
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Jersey City, New Jersey, United States Hays Recruitment Full timeHays Investor Work for Hays About Us Find Us For Job Seekers For Organizations Australia Austria Belgium Brazil Canada Chile China Colombia Czech Republic Denmark France Germany Hong Kong SAR Hungary Italy Japan Luxembourg Malaysia Mexico Netherlands New Zealand Poland Portugal Romania Singapore Spain Sweden Switzerland Thailand UAE United Kingdom United...
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Jersey City, New Jersey, United States Hays Recruitment Full timeHays Investor Work for Hays About Us Find Us For Job Seekers For Organizations Australia Austria Belgium Brazil Canada Chile China Colombia Czech Republic Denmark France Germany Hong Kong SAR Hungary Italy Japan Luxembourg Malaysia Mexico Netherlands New Zealand Poland Portugal Romania Singapore Spain Sweden Switzerland Thailand UAE United Kingdom United...
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Validation and Verification Professional
1 day ago
Jersey City, New Jersey, United States Hays Recruitment Full timeJob DescriptionWe're seeking a skilled Validation Specialist to join our team. As a key member of our organization, you'll play a crucial role in ensuring the accuracy and reliability of our computerized systems. Your primary responsibilities will include reviewing computerized systems validation documents, directing and reviewing testing, and providing...
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Data Validation Specialist
1 day ago
Jersey City, New Jersey, United States Resource Informatics Group Full timeAbout Resource Informatics GroupWe are a leading provider of data validation services. Our team is dedicated to ensuring the accuracy and integrity of client data.Job DescriptionWe are seeking a highly skilled CSV validation engineer to join our team. The successful candidate will be responsible for validating large datasets, identifying errors, and...
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Computer System Validation Expert
21 hours ago
Jersey City, New Jersey, United States Hays Recruitment Full timeRole DescriptionThe Validation Specialist plays a critical role in ensuring the accuracy and reliability of our computerized systems. Your primary responsibilities will include reviewing computerized systems validation documents, directing and reviewing testing, and providing guidance on quality issues that affect the integrity of the data or the...
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Process Validation Lead
5 days ago
Jersey City, New Jersey, United States Kasmo Global Full timeAbout UsKasmo Global is a company dedicated to delivering high-quality pharmaceutical products that meet regulatory standards.Job Role:We are seeking a highly skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring compliance with cGMP regulations and FDA/EU guidelines through commissioning, qualification,...
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Model Risk Validation Associate
6 days ago
Jersey City, New Jersey, United States SMBC Group Full timeThe anticipated salary range for this role is between $95,000.00 and $150,000.00. The specific salary offered to an applicant will be based on their individual qualifications, experiences, and an analysis of the current compensation paid in their geography and the market for similar roles at the time of hire. The role may also be eligible for an annual...