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TechDigital Corporation 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) · The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manu ...
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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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Sunrise Systems, Inc. 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 fo ...
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Sunrise Systems 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) · REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: · Sound understanding of Electronic Batch Records (E ...
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Artech 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) · 6 months Contract · The Specialist works cross-functionally to execute validation activities and prepare validati ...
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Axelon 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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Specialist, MSEO Manufacturing Systems Validation
14 hours ago
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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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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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. · Eclaros client is a leade ...
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Eclaro Summit, United StatesSpecialist, MSEO Manufacturing Systems ValidationJob 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 the Biopharmac ...
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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 the B ...
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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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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 compan ...
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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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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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Bristol-Myers Squibb Summit, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those arent 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 ...
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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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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 production ...
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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 ...
Specialist, MSEO Manufacturing Systems Validation - Summit, United States - Aequor Technologies
Description
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 in Life Science or Engineering
Duration: 6 months(Possibility of extension for the right candidate)ationDur
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.
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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