Specialist, MSEO Manufacturing Systems Validation
3 weeks ago
About TSR: TSR is a relationship-based, customer-focused IT and technical services staffing company. For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients. Mission & Vision We do not believe in building a vision around the company but building a company around our vision, which is simply; Every employee's voice matters, their effort is appreciated, and their talent is rewarded. We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner. Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.Specialist, MSEO Manufacturing Systems ValidationJob Description Location: Summit, New Jersey Type: Contract Job #79179 Our client, a leading pharmaceutical company, is hiring a MSEO Manufacturing Systems Validation Specialist on a contract basis. Job ID #: 79179 Work Location: Summit, NJ - Hybrid role, 50% on site Summary: 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 company procedures, such as CSV SOP but no limited and applicable health authority regulations. Knowledge/Skills/Education: Bachelor's degree in a life sciences, engineering or technology discipline required. 2 years relevant work experience required preferably in a pharmaceutical manufacturing environment. An equivalent combination of education, experience and training may substitute. 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 12×7 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.
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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 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 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
5 days 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
5 days 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
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Summit, United States Artech Full timeVALIDATION SPECIALIST SUMMIT NJ Hybrid Role! The pay ranges between $55.00 - $57.60 an hour! Required Skills: 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,...
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Validation Specialist
2 days 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 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 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
2 days ago
Summit, United States On-Board Companies Full timeOn-Board Services is hiring a Validation Engineer 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 Engineer
4 days 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
3 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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Summit, United States Artech Full timeValidation Engineer Pharmaceutical Summit, NJ 100% onsite Duration: 6 months(High Possibility of extension for right candidate) Highly preferred cell therapy equipment commissioning qualification. Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports,...
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Sr. Validation Engineer
2 weeks 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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Validation Engineer
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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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Validation Engineer
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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
5 days 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...
