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Validation Engineer
3 weeks ago
eTeam Raritan, United StatesIn addition to validation and regulation experience, the resource should have the following experience: · Senior Level individuals, Technology Quality GxP experienced, Experienced on Acquisition and Divestiture with previous engagement on Clients projects. Fully knowledgeable of ...
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Analytical Validation Engineer
2 weeks ago
Piper Companies Raritan, United StatesPiper Companies · is looking for an · Analytical Validation Engineer · to support commissioning and decommissioning activities for a major pharmaceutical company in the · Raritan, NJ area. · Responsibilities for the · Analytical Validation Engineer · include: · Experience ...
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Analytical Validation Engineer
2 weeks ago
Piper Companies Raritan, United StatesPiper Companies is looking for an Analytical Validation Engineer to support commissioning and decommissioning activities for a major pharmaceutical company in the Raritan, NJ area. · Responsibilities for the Analytical Validation Engineerinclude: Experience in Pharmaceutical Lab ...
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Computer System Validation Engineer
1 week ago
HCLTech Raritan, United StatesHCLTech is a global technology company, home to 211,000+ people across 52 countries, delivering industry-leading capabilities centered around digital, engineering and cloud, powered by a broad portfolio of technology services and products. We work with clients across all major ve ...
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Computer Systems Validation Engineer
1 week ago
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 ...
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AbbVie Somerville, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
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AbbVie Somerville, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
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Artech Summit, United StatesValidation 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 Validat ...
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Validation Engineer
2 weeks ago
Sun Pharmaceutical Industries New Brunswick, United StatesJob Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...
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Validation Engineer
2 days ago
Sun Pharmaceutical Industries New Brunswick, United StatesJob Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...
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validation engineers
3 weeks ago
United Pharma Technologies Inc South Plainfield, United StatesVALIDATION ENGINEERS - United Pharma Technologies, Inc. - South Plainfield, NJ So. Plainfield, NJ & other unantcptd locns nationwide. Duties: Analyze validation test data to determine whether systems or processes have met validation criteria & to identify root causes of problems ...
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Validation Engineer
2 weeks ago
Kashiv BioSciences LLC Piscataway, United StatesKey Duties & Responsibilities · Draft and implement Quality System documentation including SOPs and Traceability Matrix designed to establish good validation practices within the organization. · Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guideline ...
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Validation Engineer
1 week ago
Insight Global Parsippany, United StatesDay to Day: · Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality ...
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Validation Engineer
2 weeks ago
Hyper Recruitment Solutions Ltd Trenton, United StatesJob Reference: · J5638077 · Status: · Under Offer · Updated: · 25/08/2023 · We are currently looking for a Validation Engineer to join a leading Pharmaceutical CDMO company based in the New Jersey area. As the Validation Engineer you will be responsible for a range of activiti ...
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Validation Engineer
5 days ago
Acara Solutions, An Aleron Company Trenton, United StatesAcara Solutions is seeking a Validation Engineer for its successful client who are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability ...
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validation engineers
2 weeks ago
UNITED CONSULTING HUB, INC. Metuchen, United StatesVALIDATION ENGINEERS - UNITED CONSULTING HUB, INC. - METUCHEN, NJ Metuchen, NJ & other unantcpt'd locns nationwide. Duties: Analyze validation test data to determine whether systems or processes have met validation criteria & to identify root causes of problems for various pharma ...
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Validation Engineer
2 weeks ago
Yoh Summit, United StatesYoh is seeking a Validation Engineer for our well established pharmaceutical company. The 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 ...
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Validation Engineer
3 weeks ago
Insight Global Parsippany-Troy Hills, United States5+ years Validation specialist or engineer within Pharma or Biopharma · Experience executing and writing test protocols Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) · Comprehensive knowledge of production processes · Knowledge of Capa and De ...
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Validation Engineer
2 weeks ago
INTELLECTT INC Iselin, United StatesAnalyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. Conduct Risk based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment. Participate in medical device manuf ...
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Validation Engineer
2 weeks ago
Cynet Systems Summit, United StatesJob 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 incumben ...
Validation Engineering - Raritan, NJ, United States - BuildSubmarines
Description
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Equipment/Computer System Validation Specialist II-CAR-T Manufacturing.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to build a world without disease. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy.
This innovative strategic partnership is crafted to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? The QA Equipment/CSV Specialist II is responsible for providing quality oversight over a wide range of Equipment and Computer System Validation (CSV) activities for qualification/validation projects in the Raritan CAR-T facility to support clinical and commercial efforts.
Provide QA oversight and compliance review of validation protocols and final reports during the qualification / validation process on various equipment/instruments, facility and IT systems.
Support in evaluating all the tests to qualify critical equipment, utilities and processes.
Review open deviations and investigations relating to qualification / validation issues and help to resolve complex challenges.
Works with IT partners to ensure configuration and documentation of computerized systems to meet the requirements of CFR21 Part 11.
Review project and validation documentation for the site's QMS (Document Management/Compliance Modules) and validation projects to ensure compliance.Review and oversee execution FAT, SAT and Commissioning of Equipment.
Review and suggest continuous improvements to the validation master plan, current quality system practices, validation protocols and procedures for newly installed equipment and overall validation strategies.
Assess, Review, and approve change controls related to manufacturing, laboratory and facility systems.Perform tasks in a timely manner consistent with the safety policies, quality systems and cGMP requirements.
A minimum of a bachelor's degree in Engineering, Science or equivalent technical field is required.
A minimum of (2) years of experience in Quality Assurance related to manufacturing is required with a preference for 4 years experience.
Experience in clinical quality, method development, cell banking, or Research & Development.
Ability to interact effectively with manufacturing, automation/IT, laboratory, QA, and Facilities groups.
Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
This position is located in Raritan, NJ and may require up to 5% of domestic travel.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
