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Manufacturing Systems Validation Specialist
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Pyramid Consulting Summit, United StatesImmediate 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: · P ...
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HonorVet Technologies Summit, United StatesJob 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 ...
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Eclaro Summit, United StatesSpecialist, MSEO Manufacturing Systems Validation · Job Number: · Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Specialist, MSEO Manufacturing Systems Validation for our client in Summit, NJ. · Eclaro's client is a leader in th ...
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Diversity Nexus Summit, United StatesJob 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 ...
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Diversity Nexus Summit, United StatesJob Title: Specialist, MSEO Manufacturing Systems ValidationJob Location: Summit West, NJ (need local candidates only)Job Duration: 6 monthsEmployment Type: w2 hourlyRequiredMinimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be ...
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Bristol-Myers Squibb Summit, United States**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 productio ...
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Ascent Services Group Summit, United StatesInnova Solutions is immediately hiring for an MSEO Manufacturing Systems Validation Specialist · Position Type: Contract · Duration- 06 Months · Location- Summit, NJ · As an MSEO Manufacturing Systems Validation Specialist, you will: · Work cross-functionally to execute validat ...
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TSR Consulting Summit, United StatesAbout 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 co ...
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Aequor Technologies Summit, United StatesMinimum 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 in Life Science or Engineering · Duration: 6 months(Possibility of extension for the right candidate)at ...
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Ascent Services Group Summit, United StatesInnova Solutions is immediately hiring for an MSEO Manufacturing Systems Validation Specialist Position Type: Contract Duration- 06 Months Location- Summit, NJ As an MSEO Manufacturing Systems Validation Specialist, you will: Work cross-functionally to execute validation activiti ...
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Axelon Summit, United StatesJob description: · Your Required Skills · •5+ years of experience in building out Data pipelines in Python. · •Strong knowledge of data warehousing, ETL processes, and database management. · Proficiency in data modeling, database design, and SQL. · •3+ years of experience develo ...
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Computer Systems Validation
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HCLTech Raritan, United StatesExperience in computer systems validation, GXP regulatory knowledge and good documentation methods and CSA approaches and risk-based validation required. Prior experience in SAP ECC/S4 HANA system validation, Solman/ChaRM change control process, JIRA/XRAY/qTEST tools f ...
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Bristol-Myers Squibb Summit, United StatesSpecialist, Manufacturing Systems Validation, MS&T MSEO page is loaded · Specialist, Manufacturing Systems Validation, MS&T MSEO · Apply · locations · Summit West - NJ - US · time type · Full time · posted on · Posted Yesterday · job requisition id · R · Working with U ...
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Bristol-Myers Squibb Summit, United StatesWorking 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 li ...
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Modem System Validation Engineer
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Modem System Validation Engineer
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V-Soft Consulting Group Bedminster, United StatesModem System Validation Engineer · Primary Location: Bedminster, New Jersey · V-Soft Consulting is currently hiring for a Modem System Validation Engineer for our premier client in Bedminster, New Jersey. · Knowledge, Skills and Abilities " A firm/expert working knowledge of ...
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Modem System Validation Engineer
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V2Soft Bedminster, United StatesV2Soft ( ) is a global company, headquartered out of Bloomfield Hills, Michigan, with locations in Mexico, Italy, India, China, and Germany. At V2Soft, our mission is to provide high-performance technology solutions to solve real business problems. We become our customer's true ...
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Computer System Validation Engineer
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TK-CHAIN LLC Princeton, United StatesJob Description · Job DescriptionResponsibilities · Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes. · Coordinate and execute performance and functional testing associated with multiple concurre ...
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OMG Technology New Brunswick, United StatesJob Description · Job DescriptionSalary: $55/hr. W2 · MSEO Manufacturing Systems Validation Specialist (Summit West, NJ - ONSITE) · We are looking to hire a candidate with the skill sets mentioned and experience for one of our clients within the pharmaceutical industry. This posi ...
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Computer Systems Validation Engineer
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Cynet Systems Raritan, United StatesJob Description: · Pay Range $55hr - $62hr · Responsibilities: 7+ years of CSV experience with exposure in SAP ECC/S4 HANA system validation, Solman/ChaRM change control process, JIRA/XRAY/qTEST tools for validation required. · Working Knowledge of regulations: 21 CFR Part 11 a ...
Validation - Specialist, MSEO Manufacturing Systems Validation - Summit, United States - TechDigital Corporation
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.
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.
