Validation - Specialist, MSEO Manufacturing Systems
3 days 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 Innova Solutions Full timeInnova Solutions is immediately hiring for an MSEO Manufacturing Systems Validation SpecialistPosition Type: Contract Duration- 06 MonthsLocation- Summit, NJAs an MSEO Manufacturing Systems Validation Specialist, you will: Work cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution...
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Summit, United States Diversity Nexus Full timeJob Title: Specialist, MSEO Manufacturing Systems Validation Job Location: Summit West, NJ (need local candidates only) Job Duration: 6 months Employment Type: w2 hourly Required Minimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager requests) Bachelor's degree required...
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Summit, United States HonorVet Technologies 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 HonorVet Technologies 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, 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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Validation Specialist
1 week ago
Summit, United States SPECTRAFORCE Full timeTitle: MSEO Manufacturing Systems Validation Specialist. Location: Summit, NJ 07901/ hybridDuration: 6 months(Possibility of extension for the right candidate) W2 and Local candidates only.Summary: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...
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Manufacturing Systems Validation Specialist
4 weeks 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
1 month 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
1 month 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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Manufacturing Systems Validation Specialist
4 weeks 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 Specialist
1 month ago
Summit, United States On-Board Companies Full timeOn-Board Services is hiring a Validation Specialist in Summit, NJ! For immediate consideration please send your resume to Subject Line: Position Title and State you are Located. About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer...
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Validation Specialist
4 weeks ago
Summit, United States On-Board Companies Full timeOn-Board Services is hiring a Validation Specialist in Summit, NJ! For immediate consideration please send your resume to Subject Line: Position Title and State you are Located. About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer...
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Summit, United States Bristol-Myers Squibb Full time**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Validation Engineer
1 week ago
Summit, United States Cynet Systems Full timeJob Description: Pay Range: $79hr - $81hr Responsibilities: 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,...
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Summit, United States Sunrise Systems Full timeJob Title: Validation Engineer Job ID: (phone number removed) Location: Summit, NJ, 07901 Duration: 06 Months contract on W2 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...
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Summit, United States Sunrise Systems Full timeJob Title: Validation Engineer Job ID:(phone number removed) Location: Summit, NJ, 07901 Duration: 06 Months contract on W2100% Onsite positionPURPOSE 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...
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Summit, United States Sunrise Systems Full timeJob Title: Validation Engineer Job ID: (phone number removed) Location: Summit, NJ, 07901 Duration: 06 Months contract on W2 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...
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Validation Engineer
1 month ago
Summit, United States Cynet Systems Full timeJob Description: Pay Range: $79hr - $81hr Responsibilities: 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,...
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Validation Engineer
1 week ago
Summit, New Jersey, United States Cynet Systems Full timeJob Description: Pay Range: $79hr - $81hr Responsibilities: 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,...
