Validation Manager
4 weeks ago
- Responsible for validation programs in support of GMP manufacturing
- Responsible for facility, utility and equipment qualification programs
- Responsible for QA role in process and assay validation programs
- Review or author validation related documents such as design specification, URS, FAT, SAT, IQ, OQ, PQ for utility and equipment
- Assume QA lead role in software validation
- Maintain and update validation master plans
- Execute validation protocols as required
- Oversee QA aspects of calibration and preventive maintenance programs used in GMP manufacturing
- Supervisor, mentor validation staff with the goal of building a sustaining validation team
- Serve as the primary QA representative for interaction with internal function departments and contractor on validation activities
- BS/MS in life science or related field
- 12+ years experience in drug/biologics industry in GMP production environment in roles of validation/engineering
- 10+ years experience in facility, utility, equipment, instrument validation
- Experience in biotechnology facility validation is required
- Familiar with GMP operational principles and practices
- QC experience helpful
- Works independently, self-motivated, and results oriented
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Validation Lead
1 month ago
Jersey City, United States RxCloud Full timeJob Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...
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Validation Lead
4 days ago
Jersey City, United States RxCloud Full timeJob Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...
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Validation Engineer
3 weeks ago
Jersey City, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and client's corporate principles, quality policies, standards, and core values. You will work closely with instrument vendors, facilities, IT, and lab...
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Validation Engineer
1 month ago
Jersey City, United States Cynet Systems Full timeJob Description: Pay Range $50hr - $55hr Support cross functional teams in processing documents (assist in document editing, review, approvals). ssist in process improvements for Document Control Management/Training processes. Revise SOPs related to Document Control/Training on an as needed basis. Help to support the management and maintenance the...
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Validation Lead with Lab Vantage
6 days ago
Jersey City, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities:Validation Lead with 10+ years of experience to with Lab Vantage LIMS implementation team who would be responsible for :Planning and implementation of validation projects for Compliant GxP Computerized Systems, particularly for Lab Vantage LIMS systemCreation, Review and in-time delivery of the Validation documentation but not limited to the...
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Product Validation Specialist
7 days ago
Jersey City, United States CHUBB Full timeChubb’s North American Digital Consumer Division brings together the digital products and services of Chubb’s North American consumer businesses. We are a diverse, dynamic, and nimble team that uses technology, smarts, and a customer-centric focus to build and digitally distribute a diverse portfolio of digital products and services at the right time...
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QA Validation Engineer
4 days ago
Jersey City, United States Themesoft Inc. Full timeJob Title:QA Validation Engineer (With ETQ) Location: Jersey City / NJ Duration: Long Term Qualifications:Advanced knowledge of end-to-end PV procedural requirementsAbility to review/direct PV procedural documents to ensure compliance with international standards and regulations while also promoting a lean and efficient procedural framework.Mid-level...
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Validation Engineer
2 months ago
New Jersey, United States LS Solutions Inc. Full timeKey Responsibilities Strong Experience in Computer Systems Validation (CSV) within the pharmaceutical industry. Required Bachelor's degree in pharmaceutical Science OR related field of study. Schedule and plan equipment and process qualification workload to meet approved schedules. Handle multiple projects and be able to work independently as required....
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Jersey City, United States Dtcc Full timeAre you ready to make an impact at DTCC? Do you want to work on innovative projects, collaborate with a dynamic and supportive team, and receive investment in your professional development? At DTCC, we are at the forefront of innovation in the financial markets. We're committed to helping our employees grow and succeed. We believe that you have the skills...
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Validation (CSV) Project Manager
2 weeks ago
Foster City, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Project Planning: Develop comprehensive project plans for validation activities, outlining scope, timelines, resources, and deliverables. Collaborate with cross-functional teams to ensure alignment with project goals. GMP Compliance: Ensure all validation processes adhere to GMP guidelines and other relevant regulatory standards. Stay...
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Manager, Core Firmware Validation
3 weeks ago
Foster City, United States Zoox, Inc. Full timeFoster City, CA / Software Embedded Software & Systems Integration / Full-time/ Hybrid. In the role of Core Firmware Validation Engineering Manager, you will be helping to define and execute the strategic verification and validation vision of the C Manager, Validation, Firmware, Validation Engineer, Firmware Engineer, Technology, Management
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Manager, Core Firmware Validation
4 days ago
Foster City, United States Zoox Full timeIn the role of Core Firmware Validation Engineering Manager, you will be helping to define and execute the strategic verification and validation vision of the Core Firmware engineering teams at Zoox. You will direct the activities of a team of Core Firmware component verification and validation engineers while coordinating and collaborating with other...
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Senior Validation Project Manager
3 weeks ago
Foster City, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. Leads...
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Validation Engineer
3 weeks ago
Foster City, United States Zoox Full timeThe Component and System Hardware Validation team at Zoox is responsible for ensuring our components and sub-systems on the Zoox robotaxi meet all functional and reliability targets needed to facilitate our autonomous mobility service. Our team has an action-biased culture marked by integrity, humility, competence, and passion for the Zoox mission and the...
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Validation Engineer
3 weeks ago
Foster City, United States Zoox Full timeThe Component and System Hardware Validation team at Zoox is responsible for ensuring our components and sub-systems on the Zoox robotaxi meet all functional and reliability targets needed to facilitate our autonomous mobility service. Our team has an action-biased culture marked by integrity, humility, competence, and passion for the Zoox mission and the...
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Validation Engineer
4 weeks ago
Peachtree City, United States Gerresheimer Full timeJob DescriptionJob DescriptionCompany DescriptionGerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer...
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Validations Engineer
6 days ago
Salt Lake City, United States DISCGENICS INC Full timeJob DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary: The Validations Engineer will fill an important need at DiscGenics through helping the company...
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Validations Engineer
4 weeks ago
Salt Lake City, United States DISCGENICS INC Full timeJob DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary: The Validations Engineer will fill an important need at DiscGenics through helping the company...
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SAP Validation Lead
4 days ago
California City, United States RxCloud Full timeAbout the job SAP Validation Lead Job Requirements: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and...
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SAP Validation Lead
1 month ago
California City, United States RxCloud Full timeAbout the job SAP Validation Lead Job Requirements: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations...