GAMP jobs in New Jersey

Remote or Addison, Texas

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Today

RESPONSIBILITIES: Kforce is working with a client in search of a Lead Solutions Engineer to join their team in Addison, TX. Summary: We are seeking a Lead Solutions Engineer to spearhead the technical design and delivery of end-to-end systems within a regulated software environment. This is a newly created role within our Biomass and Software organization, offering the opportunity to shape a high-impact project from the ground up. Duties Include: * Lead the technical design and integration of

Full-time

$120,000 - $180,000 annually

Benchling Validation Consultant

Remote

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8d ago

Benchling Validation Consultant KEY RESPONSIBILITIES: Strong understanding of CSA (Computer Software Assurance) In-depth knowledge of GAMP 5, 21 CFR Part 11, and Annex 11 compliance requirements Hands-on experience with Benchling cloud-based LIMS platform Validation efforts for periodic SaaS/cloud releases, patches, upgrades, and enhancements Assess GxP impact of each release and update validation deliverables accordingly. Develop Validation Plans that align with the platform s release cycle and

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Contract

$90 - $100

Controls Engineer (DeltaV)

Remote

•

Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

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Full-time

USD 120,000.00 - 160,000.00 per year

Computer System Validation Engineer

Hybrid in Raritan, New Jersey

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19d ago

Role - Computer System Validation Engineer Location - Raritan, NJ(Hybrid) Job Details: 5-10 years experience in Computer System Validation of GxP systems Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation 5+ years of experience in validating SAP application implementation, test script review, test execution review, test defect management. Has working experience in any one or

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Third Party, Contract

$55 - $60

Senior CSV Engineer

Remote or Massachusetts

•

Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Computer System Validation - CSV Engineer

Remote or New Jersey

•

Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

Validation Engineer II

Morris Plains, New Jersey

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Today

Job Description Summary The Validation Engineer II, assists with the authoring, executing and reviewing of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Morris Plains, NJ Number of positions open: 2 Responsibilities: Supports the development of Validation/Qualification documents including drafting risk assessments, qualification protocols, deviations, and reports. Supports the execution of validation/qualification activities fo

Full-time

USD 70,000.00 - 130,000.00 per year

CSV Engineer

Raritan, New Jersey

•

Today

Roles & Responsibilities: 7-10 years' experience in Computer System Validation of SAAS systems, and Cloud systems. Must have experience in Agile methodology and handled multiple releases in parallel. Has working experience in any one or two of the following domains Tool validation like Service NOW, 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 ind

Full-time

Computer System Validation Engineer

New Jersey

•

Today

Roles & Responsibilities: Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 3-7 years of experience in CSV within pharmaceutical, biotech, or medical device industries. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines. Experience with ERP, LIMS, MES, or other GxP systems. Extensive Experience in HPALM with Manual testing. Deep knowledge in Defect Management Life cycle. Proficient in writing validation protocols, reports, and SOPs

Full-time

Computer System Validation (CSV) Engineer

Remote or Massachusetts

•

Today

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

Full-time

SAP Validation consultant Remote Location

Remote

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8d ago

King of Prussia PA Job Description: >> 12+ years Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems >> Perform review for GxP systems to ensure compliance with regulatory requirements >> Working knowledge on end-to-end validation of GxP applications and is able to perform documentprocess Compliance Analysis >> Adept with Agile and Waterfall methodology-based software development Compliance a

Contract, Third Party

$70 - $70

R&D Business Systems Lead (BSA/PM) with Life Sciences -GxP Expereince

Remote

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3d ago

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: R&D Business Systems Lead (BSA/PM) Location: Cambridge, MA (Remote) Duration: 12+ months Qualifications & Experience Required: 8+ years of combined experience in Life Sciences IT, including:Minimum 4 years in a GxP-regulated system administrator or support capacity.Minimum 4 years in project management, delivering cross-functional systems in R&D or Clinical domains.Str

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Contract

Depends on Experience

SDMS Validation Engineer

Remote

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15d ago

Role: Scientific Data Management System (SDMS) Validation Engineer Location: NEAR SHORE - South America/Canada Length: Long term rolling contract CSV engineers and for the applications: Discoverant, BIOVIA ELN, SDMS, Empower, LabX, SoftMax Pro. Job Description: Job Overview: The SDMS (Scientific Data Management System) Validation Engineer is responsible for the qualification, validation, and compliance of scientific data management systems within laboratory environments, particularly in regula

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Contract

$30 - $35

Commercialization & Validation Engineer

Remote or Hybrid

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Today

The CSA Validation SME is a key stakeholder within the ELC CSA Center of Excellence (COE). This role ensures the integrity of CSA projects with a strong focus on risk assessment, compliance, and regulatory adherence. Acting as a subject matter expert (SME), the CSA Validation SME serves as a bridge between COE leadership, protocol authors, and testers. The SME will ensure projects meet regulatory, data integrity, and organizational (R&D/GSC/IT) policies while maintaining best practices in valida

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Contract

$70 - $75 per hour

Technical Lead Oracle ERP (GAAP Workstream)

Remote

•

Yesterday

Position: Technical Lead Oracle ERP (GAAP Workstream) Location: Denver, CO; Cedar Rapids, IA; or Philadelphia, PA (preferred); Remote is okay for the right candidate Duration: 6 Month Contract (Likely Extensions as this is a 2-3 year program) Key Responsibilities: Lead the GAAP workstream within the Oracle Cloud Financials ERP program, ensuring alignment with the overall implementation strategy and timeline. Collaborate with finance, compliance, and technology teams to define and execute the tr

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Contract, Third Party

Depends on Experience

Technical Lead Oracle EPM (GAAP Workstream)

Remote

•

Yesterday

Job Title: Technical Lead Oracle EPM (GAAP Workstream) Location: Denver, CO; Cedar Rapids, IA; or Philadelphia, PA (preferred); (Remote is okay for the right candidate)Duration: 6 Month Contract (Likely Extensions as this is a 2-3 year program) Key Responsibilities: Lead the GAAP workstream supporting the transition from IFRS17 to U.S. GAAP, ensuring alignment with the Oracle EPM implementation timeline and architecture. Collaborate with finance, compliance, and technology teams to define and e

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Contract, Third Party

Depends on Experience

Senior Accountant (Payroll/GL/NetSuite/CPA)

Remote

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2d ago

Title: Senior Accountant (Payroll/GL/NetSuite/CPA) Location: Remote Duration: 3-6 months contract Description: The key qualifications we are looking for are payroll and GL accounting experience, NetSuite, and advance Excel skills. EDUCATION: Completion of a bachelor s degree in accounting or financeCPA a plus SPECIALIZED KNOWLEDGE, SKILLS & ABILITIES: NetSuite or other similar ERP experienceProficient with Microsoft Excel and WordAccounting research, reconciliation, analysis, and reporting ski

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Contract

Depends on Experience

SAP FI Consultant - GL, AR & AP Consultant

Hybrid in Edison, New Jersey

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2d ago

RAYVEN IT Solutions is a leading IT Consulting firm offers a comprehensive range of services that are domain specific with a strong focus on technology, business process & practices. Founded by top-notch profs with the vision of bridging the gap between people, process & technology. RAYVEN has the capability & resources to help clients realize their technology driven business transformation initiatives. We are specialized & provide solution-based services to our clients in the areas of SAP/ERP.

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Contract

Depends on Experience

Accounting Specialist (Accounts Payable) - Marlton, NJ - Fulltime

Voorhees Township, New Jersey

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23d ago

Job Title: Accounting Specialist (AP/AR) Location: Marlton, NJ (onsite) Employment Type: Full-Time Final Round: In-Person Interview Qualifications: Bachelor s degree in accounting, Finance, or a related field.5-7 years of accounting experience, in accounting.Experience with U.S. accounting standards (GAAP)Proficiency in accounting software such as QuickBooks, Yardi, AppFolio, or similar platformsStrong Excel skills (pivot tables, VLOOKUP, etc.)Excellent communication, organizational, and prob

Easy Apply

Full-time

Depends on Experience

Lead Validation Analyst ( Gxp,Gmp)

Remote

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11d ago

Lead Validation Analyst ( Gxp/Gmp) Remote 12+Months Contract Mandatory Skills: GMP/GXP Job Summary: We are seeking an experienced Validation Lead to oversee and lead validation activities in compliance with GMP (Good Manufacturing Practice) and GxP (Good Clinical/ Laboratory Practice) regulations. The ideal candidate will have a strong background in managing validation processes for systems, equipment, and processes within regulated environments, ensuring compliance, quality, and safety standard

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Third Party, Contract

Depends on Experience

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GAMP jobs in New Jersey, USA