Validation - Specialist, MSEO Manufacturing Systems Validation
3 weeks ago
Job Description: Minimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works. The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle. The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant Client procedures, such as CSV SOP but no limited and applicable health authority regulations. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:•Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation. •Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotation •Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles •Understanding the concept of Critical thinking for Computerized Systems •Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs) •Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods •With advanced technical document writing and time management skills, including ability to prioritize and manage expectations •Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties Education and Experience: •Bachelor's degree in a life sciences, engineering or technology discipline required •Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment. •An equivalent combination of education, experience and training may substitute. Additional Job Requirements: None
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Summit, United States Sunrise Systems, Inc. Full timeJob Description: Minimum 50% onsite required every week (Candidate is supposed to align the onsite days with manager and be available onsite when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy...
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Summit, United States Axelon Full timeJob Description: Minimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy...
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Summit, United States Axelon Full timeJob Description: Minimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy...
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Summit, United States Eclaro Full timePosition Overview: The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works. The Specialist will...
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SUMMIT, NJ, United States Axelon Full timeJob Description: Minimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy...
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Manufacturing Systems Validation Specialist
3 hours ago
Summit, United States Pyramid Consulting, Inc Full timeImmediate need for a talented Manufacturing Systems Validation Specialist . This is a 06+ Months Contract opportunity with long-term potential and is located in Summit, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID:24-17823Pay Range: $47 - $57/hour. Employee benefits include, but are not limited to,...
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Manufacturing Systems Validation Specialist
4 hours ago
Summit, United States Pyramid Consulting Full timeImmediate need for a talented Manufacturing Systems Validation Specialist . This is a 06+ Months Contract opportunity with long-term potential and is located in Summit, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID:24-17823 Pay Range: $47 - $57/hour. Employee benefits include, but are not limited to,...
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Validation Engineer
2 weeks ago
Summit, United States System One Holdings, LLC Full timeJob Title: Validation Engineer Location: Summit, NJ Type: Contract Responsibilities Maintains qualified equipment systems in compliance with policies, guidelines and procedures: Develops qualification protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation...
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Validation Engineer
5 hours ago
Summit, United States Axelon Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment...
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Validation Engineer
4 hours ago
Summit, United States Mindlance Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment...
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Validation Engineer
3 hours ago
Summit, United States LanceSoft Full timeTitle: Engineering - Validation Engineer Location: Summit NJ 07901 Duration: 6 months(High Possibility of extension for right candidate) Comments: 100% onsite Highly preferred cell therapy equipment commissioning qualification. Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability...
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Sr. Validation Engineer
6 days ago
Summit, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities. This role will be responsible for drafting, reviewing and approving qualification protocols/reports and any associated documentation in support of CQV activities for a new facility. The Role...
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Equipment Validation Engineer
2 weeks ago
Summit, United States Yoh, A Day & Zimmermann Company Full timeYoh is looking for an Equipment Validation Engineer to come in and join our pharmaceutical client.Industry: PharmaceuticalLocation: Summit, NJ (on site)Compensation: $70-$78/hr (cannot accept C2C for this opportunity) Type: 6 Month ContractThe Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use...
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Equipment Validation Engineer
2 weeks ago
Summit, United States Yoh, A Day & Zimmermann Company Full timeYoh is looking for an Equipment Validation Engineer to come in and join our pharmaceutical client.Industry: PharmaceuticalLocation: Summit, NJ (on site)Compensation: $70-$78/hr (cannot accept C2C for this opportunity) Type: 6 Month ContractThe Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use...
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Engineering - Validation Engineer
7 hours ago
Summit, United States Omni Inclusive Full time100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and...
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Engineering - Validation Engineer
4 hours ago
Summit, United States HonorVet Technologies Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment...
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Equipment Validation Engineer
8 hours ago
Summit, United States Pyramid Consulting Full timeImmediate need for a talented Equipment Validation Engineer. This is a 06+ Months Contract opportunity with long-term potential and is located in Summit, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID:24-21967 Pay Range: $70 - $77/hour. Employee benefits include, but are not limited to, health insurance...
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Equipment Validation Engineer
2 minutes ago
Summit, United States Pyramid Consulting, Inc Full timeImmediate need for a talented Equipment Validation Engineer. This is a 06+ Months Contract opportunity with long-term potential and is located in Summit, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID:24-21967Pay Range: $70 - $77/hour. Employee benefits include, but are not limited to, health insurance...
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Validation Engineer
19 hours ago
summit, United States Joulé Full timeJob Title: Validation EngineerLocation: Summit, NJType: ContractResponsibilitiesMaintains qualified equipment systems in compliance with policies, guidelines and procedures:Develops qualification pro...
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QA Associate Specialist
2 days ago
Summit, United States Omni Inclusive Full timeTop Skills:- 2+ years of Document Control & Reporting Experience,- Veeva experience preferred- Technical troubleshooting- Self motivated, independent, great communication- Experience working cross-functionally Position Summary:The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell...
