Current jobs related to Validation Specialist - Summit, New Jersey - Axelon

  • Data Systems Validation Specialist

    3 days ago

    Summit, New Jersey, United States Axelon Full time

    Job OverviewAxelon is seeking a highly skilled Data Systems Validation Specialist to join our team. As a key member of our operations department, you will be responsible for ensuring the accuracy and reliability of our electronic systems.ResponsibilitiesCreate and execute computer system validation documents, including UAT, URS, OQ, and PQ.Guide QC end users...

  • Validation Engineer for Life Sciences

    3 days ago

    Summit, New Jersey, United States Azzur Group Full time

    Computer System Validation (CSV) Specialist Job DescriptionWe are seeking an experienced CSV Specialist to support the validation of computer systems, including environmental monitoring equipment such as particle counters, and ensure compliance with regulatory requirements. The CSV Specialist will be responsible for generating validation deliverables,...

  • Computer Validation Expert

    3 days ago

    Summit, New Jersey, United States Azzur Group Full time

    Azzur Group OverviewAzzur Group is committed to delivering quality-driven solutions that propel life science companies toward success. Our team of experts is dedicated to helping organizations navigate the complexities of regulatory requirements and ensure compliance with industry standards.We are seeking an experienced Computer System Validation (CSV)...

  • Electronics Systems Validation Expert

    2 days ago

    Summit, New Jersey, United States LanceSoft Full time

    Job Overview:LanceSoft is seeking an accomplished expert in electronic systems validation and quality assurance to join our team as a Master Data Specialist. This individual will be responsible for ensuring the accuracy and completeness of electronic systems Master Data, as well as providing operational support and guidance to QC end-users.The ideal...

  • Validation - Training Specialist 54918

    4 days ago

    Summit, New Jersey, United States Futran Tech Solutions Pvt. Ltd. Full time

    Position Summary: The Training Specialist, Instructional Design & Systems Training is a full-time role. The primary focus for this role is to lead and manage the instructional design, the training development for instructor-led, on-the-job, and computer-based training courses that support the Business Process Management portfolio of projects. This role is...

  • Quality Assurance Specialist for Computer Systems

    3 days ago

    Summit, New Jersey, United States Azzur Group Full time

    Quality Assurance Specialist for Computer Systems Job DescriptionWe are seeking an experienced Quality Assurance Specialist for Computer Systems to support the validation of computer systems, including environmental monitoring equipment such as particle counters, and ensure compliance with regulatory requirements. The Quality Assurance Specialist will be...

  • Environmental Monitoring Systems Specialist

    3 days ago

    Summit, New Jersey, United States Azzur Group Full time

    About Azzur GroupAzzur Group is a compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. Our team of experts is dedicated to helping organizations navigate the complexities of regulatory requirements and ensure compliance with industry standards.We are seeking an experienced...

  • IT Specialist

    2 days ago

    Summit, New Jersey, United States BCforward Full time

    About the Role:We are seeking a highly skilled IT Specialist to join our team in Summit, NJ. As a Technical Support Professional, you will be responsible for providing comprehensive technical support for laboratory IT environments in a Cell Therapy Operations setting.Key Responsibilities:Provide technical support for laboratory IT environments, including...

  • Regulated Environment IT Specialist

    3 days ago

    Summit, New Jersey, United States Axelon Full time

    Job DescriptionAxelon is seeking a highly skilled Regulated Environment IT Specialist to join our team. As a key member of our operations department, you will be responsible for ensuring the accuracy and reliability of our electronic systems in a regulated environment.ResponsibilitiesCreate and execute computer system validation documents, including UAT,...

  • Data Management Specialist

    2 days ago

    Summit, New Jersey, United States LanceSoft Full time

    About the Role:This position is a key part of our team at LanceSoft, focused on ensuring the smooth operation and validation of our electronic systems. As a Master Data Specialist, you will play a critical role in creating, deploying, reviewing, and sustaining electronic systems Master Data.We are looking for an experienced professional with expertise in...

  • QC Electronic Systems Specialist

    4 weeks ago

    Summit, New Jersey, United States Rangam Full time

    We are seeking a QC Electronic Systems Specialist responsible for creating, deploying, and sustaining electronic systems Master Data, including LIMS, ERP, and MES. The ideal candidate will have strong experience in computer system validation, operational support, and system integration within a regulated environment.Key Responsibilities:Create and execute...

  • Master Data Specialist

    1 week ago

    Summit, New Jersey, United States TSR Consulting Full time

    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...

  • Master Data Specialist

    2 days ago

    Summit, New Jersey, United States LanceSoft Full time

    Job Title: Master Data Specialist Location: Summit, NJ 07901 Duration: 12 Months Work Schedule: Mon-Fri(normal business hours) 50% onsite Bachelor's degree required Must Haves: Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems. Position Summary: •...

  • Master Data Specialist

    3 weeks ago

    Summit, New Jersey, United States Veracity Solutions Full time

    Master Data SpecialistSummit - West, New Jersey12 Months Contract50/50 hybrid role, 3 days onsite one week, 2 days onsite the next.Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement.Duties/ResponsibilitiesCreate and execute computer...

  • Master Data Specialist

    4 weeks ago

    Summit, New Jersey, United States Veracity Full time

    Master Data Specialist Summit - West, New Jersey 12 Months Contract 50/50 hybrid role, 3 days onsite one week, 2 days onsite the next. Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement. Duties/Responsibilities Create and execute...

  • IT Lab Computing Support Specialist

    3 days ago

    Summit, New Jersey, United States Eclaro Full time

    IT Lab Computing Support Specialist Job Number: 25-03999 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for an IT Lab Computing Support Specialist for our client in Summit, NJ. ECLARO's client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference...

  • Data Management Specialist

    4 weeks ago

    Summit, New Jersey, United States Sunrise Systems, Inc. Full time

    Job Title: Master Data SpecialistJob ID: 25-06798Location: Summit, NJ, 07901Duration: 12+ months of Contract on W250% onsiteBachelor's degree requiredWork Schedule: Mon-Fri (normal business hours)Must Haves:Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic...

  • Data Systems Specialist

    6 days ago

    Summit, New Jersey, United States Innova Solutions Full time

    At Innova Solutions, we have an exciting opportunity for a Data Systems Specialist to join our team.Key Responsibilities:Create and execute system validation documents, guiding QC end-users on the development of system enhancements with user requirements and business drivers.Provide electronic systems operational support and troubleshooting to...

  • IT Lab Computing Support Specialist

    2 days ago

    Summit, New Jersey, United States BCforward Full time

    IT Lab Computing Support Specialist BCforward is currently seeking a highly motivated IT Lab Computing Support Specialist in Summit, NJ .Job Title: IT Lab Computing Support SpecialistLocation: 556 Morris Avenue, Summit, NJ 07901 Pay Rate: $36/hr Schedule: 40 hours/week (flexible schedule; nights and weekends required) Job Summary: We are seeking a dedicated...

  • Master Data Solutions Analyst

    1 week ago

    Summit, New Jersey, United States TSR Consulting Full time

    About TSR Consulting Services TSR Consulting Services provides specialized IT and technical services staffing solutions to clients in various industries. Our goal is to deliver high-quality candidates who meet the specific needs of our clients. We pride ourselves on our ability to understand the complex requirements of our clients and match them with the...

Validation Specialist

1 month ago

Summit, New Jersey, United States Axelon Full time
Job Description:

The Specialist plays a crucial role in executing validation activities and preparing deliverables for the S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This position requires strong collaboration with site Business Owners, CI Owners, Quality, and the global EMES team to ensure data integrity throughout the CSV lifecycle.

Responsibilities:
  • Execute validation activities and prepare deliverables for S12 EMES
  • Partner with site Business Owners, CI Owners, Quality, and the global EMES team
  • Ensure data integrity throughout the CSV lifecycle
Requirements:
  • Bachelor's degree in a life sciences, engineering, or technology discipline
  • Minimum 2+ years relevant work experience preferably in a pharmaceutical manufacturing environment
  • Sound understanding of Electronic Batch Records (EBR), Review by Exception (RBE), and Recipe Authoring/Validation
  • Ability to work extended hours or modified work schedules
Competencies:
  • Critical thinking for Computerized Systems
  • Knowledge of cGMP, GxP, GAMP, SDLC regulations, and ALCOA+ principles
  • Experience with MES infrastructure, ALM, Veeva document/change management systems, and WebMethods middleware
Estimated Salary: $50-$59 per hourWork Requirements:

Minimum 50% onsite work required every week. The candidate must align onsite days with their manager and be available onsite when requested.