GAMP Jobs in New Jersey

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Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree
Posted 13 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Raritan, New Jersey, USA

Full-time

Role & Responsibilities: 3-7 years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area. Has working experience in any one or two of the following domains Tool validation like ServiceNow, Automation tools, JIRA . Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. pplication of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 2
Posted 60+ days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end
Posted 60+ days ago | Updated 3 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 3 hours ago

SAP Finance FICO Consultant

URSI Technologies Inc.

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Remote

Contract

SAP Finance FICO Consultant San Francisco, CA Remote Remote Qualifications The ideal candidate will have hands-on experience in SAP S4HANA and ECC, a strong understanding of GAMP 5, cGMP, and SOX compliance requirements, and proven application support skillsKey Responsibilities: Provide application support for SAP FICO modules within a regulated IT environmentTranslate business requirements into SAP solutions using SAP Best Practices, FIORI apps, and embedded analyticsJob description : 9+ to 15
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Posted 15 days ago | Updated 7 days ago

CSV Lead

Prudent Technologies and Consulting

•

Raritan, New Jersey, USA

Third Party, Contract

Role - CSV Lead Location - Raritan, NJ(Hybrid) Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool val
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Posted 5 days ago

AP/AR & Invoicing Accounting Specialist - Ridgewood, NJ - 2 day a week

MetaSense, Inc.

•

Ridgewood, New Jersey, USA

Full-time

Employment Type: Part-Time 23-30 Hours Week Company Overview: We are seeking a skilled and detail-oriented Accounting Specialist to manage invoicing, accounts payable (AP), and accounts receivable (AR) functions. This role is critical to maintaining accurate financial records and ensuring smooth day-to-day accounting operations. Key Responsibilities: Invoicing & Revenue Tracking Generate and send tenant rent invoices, lease charges, and other billablesTrack incoming payments and apply to the cor
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Posted 10 hours ago

Manager, Commercial IT Systems

Garshan Associates

•

Florham Park, New Jersey, USA

Full-time

Manager, Commercial IT Systems Florham Park, NJ $120,000 - $150,000 The Manager, Commercial IT Systems will be responsible for effective provisioning, operation, installation/configuration and maintenance of web applications for the Commercial business users. The incumbent will evaluate digital solutions such as marketing platforms, websites and sales applications, and provide technical support, guidance and hands-on delivery in the planning, implementation, and ongoing operation of Commercial
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Posted 28 days ago | Updated 8 hours ago

Infrastructure Business Analyst

TEKsystems c/o Allegis Group

•

Branchburg, New Jersey, USA

Full-time

Description We are seeking a skilled and motivated Infrastructure Business Analyst to support IT initiatives within a regulated manufacturing environment in Branchburg, NJ. This role is ideal for professionals with a background in business analysis or project coordination, particularly within GMP-compliant pharmaceutical or manufacturing settings. You will play a key role in bridging the gap between IT infrastructure and operational technology (OT), ensuring seamless integration and compliance.
Posted 4 days ago | Updated 11 hours ago

Full Stack Lead Engineer

Akshaya Inc

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Remote

Contract

Job Description: Tech Stack: LAMP stack migration Node.js, Vue.js, CloudSQL, Google Cloud Platform Key ResponsibilitiesLead migration of legacy LAMP stack applications to modern Google Cloud Platform-based architectureBuild high-traffic, consumer-facing products from the ground upCollaborate with Product, QA, and Ops teams to align engineering effortsDesign and develop new products including prototyping and testingManage full product development life cycleIdentify and resolve technical issues to
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Posted 5 hours ago

Accounting Specialist (AP/AR & Invoicing)

MetaSense, Inc.

•

Ridgewood, New Jersey, USA

Part-time

Company Overview: We are seeking a skilled and detail-oriented Accounting Specialist to manage invoicing, accounts payable (AP), and accounts receivable (AR) functions. This role is critical to maintaining accurate financial records and ensuring smooth day-to-day accounting operations. Key Responsibilities: Invoicing & Revenue Tracking Generate and send tenant rent invoices, lease charges, and other billablesTrack incoming payments and apply to the correct accountsCoordinate with property manage
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Posted 6 hours ago

Raw Materials Technical Specialist

Aditi Consulting

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Remote or Cambridge, Massachusetts, USA

Contract

Payrate: $38.00 - $40.00/hr. Summary: The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing t
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Posted 2 days ago | Updated moments ago

Full stack Developer-LAMP

Akshaya Inc

•

Remote

Third Party, Contract

Job Title :LAMP Full stack Developer Location: Remote Experience: 15+Years Required Description: Lead efforts to build and migrate features from the current LAMP stack application to Google Cloud using state of the art techstack using NodeJs, VueJS, CloudSQL and Google Cloud technologies. Deep knowledge building full stack apps using VueJS, NodeJS, HTML5, CSS3, JavaScript and microservices. Working knowledge of PHP applications and ideally have experience migrating them.
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Posted 4 hours ago

Broker Dealer Regulatory Reporting Controller

MDMS Recruiting

•

Jersey City, New Jersey, USA

Full-time

NO SPONSORSHIPW-2 ONLYHYBRID - need to be local to Jersey City, NJ Our Direct Client is seeking a Broker Dealer Regulatory Reporting Controller in Jersey City, NJ (Hybrid) for an FTE role. Analytical skills in order to be able to give an independent and relevant opinion on the control framework or the correct application of regulations on broker dealer operations.Strong audit skills and good knowledge of SEC and Finra regulationsProduct knowledge in Broker Dealers derivatives, loans, funding ve
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Posted 19 days ago | Updated 4 hours ago

Data Integrity Manager

HAYS

•

Princeton, New Jersey, USA

Contract

Data Integrity Manager - Contract - Princeton, NJ/Hybrid - $64.77 - $64.77/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our client is
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Posted 48 days ago | Updated 11 hours ago

Finance Manager

First Tek, Inc.

•

Piscataway, New Jersey, USA

Full-time

Job Summary: Manages daily, weekly, and/or monthly financial reporting; leads monthly financial statement preparation; supervises year-end audit and tax preparation for external CPA; assist with special projects as assigned; approve work prepared by domestic and offshore accounting staff; Performs complex reconciliations and financial analysis, interpretation, and reporting. Roles & Responsibilities: Perform and supervise monthly financial closing procedures and compliance with appropriate GAAP
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Posted 21 days ago | Updated 6 days ago

Process Engineer

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.
Posted 59 days ago | Updated 3 hours ago

GMP/GDP Pharma Quality Engineer (ONSITE)(No C2C/H1B)

NetSource, Inc.

•

Ewing Township, New Jersey, USA

Contract

No C2C/H1B Please note that this is a 5+ months contract position. Work Location: Titusville, NJ Required: BA/BS Technical / Life Science Desirable: MA/MS/MBA Business / Technical /Life ScienceSupport Quality and Compliance Initiatives from Enterprise Quality and/or Global Business QualityEssential knowledge and skills Knowledge 5 years experience in the Pharmaceutical or related industry; Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP; Up-to-date knowledge of DEA regu
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Posted 3 hours ago | Updated 3 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 18 days ago | Updated 3 hours ago

Process Validation Engineer

Katalyst Healthcares and Lifesciences

•

East Windsor, New Jersey, USA

Full-time

Responsibilities: Previous experience as a validation engineer in an aseptic pharmaceutical fill/finish environment. Prior experience executing validation protocols on a pharmaceutical fill/finish line. Specific line components include. Lyophilizers. Depyrogenation tunnels. Autocalves. Previous experience with the project management requirements of validation project in a GMP environment. Requirements: Managing validation schedule. Communication of delays and changes to timelines. Coor
Posted 60+ days ago | Updated 3 hours ago