gxp Jobs in new jersey

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GxP Business Analyst/Project Manager

Eliassen Group

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Anywhere, US

Contract

Description: **Remote** Our Biotechnology client is looking for a GxP Business Analyst/Project Manager to come on for a long-term contract. This person is needed to help "keep the lights on" with respect to legacy systems that are being used for submissions to meet regulatory requirements across the globe. Regulatory requirements are constantly evolving, and our client has to keep product documentation up to date in order to be in compliance and continue to do business in different countries
Posted 60+ days ago | Updated 4 hours ago

SAP Project Manager-Bio-Pharma

NexInfo Solutions, Inc.

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Remote

Contract, Third Party

About Nexinfo: NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges
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Posted 1 day ago

Lead Agile Coach

Intento Analytics LLC

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Remote

Contract

Skills required: Agile, Lead, Certification , GXP, compliance and Audit , Jira and Pharma industry Required Qualifications SAFe Certified professional with deep expertise in Apptio TargetProcess, Jira, and scaled agile delivery frameworks . Demonstrated knowledge of GxP-regulated projects in the pharmaceutical industry, ensuring compliance and audit readiness during Agile delivery. Skilled in the development and management of Objectives and Key Results (OKRs) to align program delivery with st
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Posted 9 hours ago

Lead Agile Coach

Intento Analytics LLC

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Remote

Contract

Job Title : Lead Agile Coach Location: 100% Remote Work Authorization: (H1B/ EAD/L2 EAD/EAD/OPT) Skills required: Agile, Lead, Certification , GXP, Compliance and Audit , Jira and Pharma industry Required Qualifications SAFe Certified professional with deep expertise in Apptio TargetProcess, Jira, and scaled agile delivery frameworks . Demonstrated knowledge of GxP-regulated projects in the pharmaceutical industry, ensuring compliance and audit readiness during Agile delivery. Skilled in the d
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Posted 10 hours ago

Business Analyst

NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil
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Posted 6 days ago | Updated moments ago

Veeva Presales Consultant

NexInfo Solutions, Inc.

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Remote

Contract

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content
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Posted 29 days ago | Updated 1 hour ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

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Remote

Contract, Third Party

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce
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Posted 5 days ago | Updated 10 hours ago

Data Engineer

Comptech Associates Inc

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Raritan, New Jersey, USA

Contract

Job title: Data Engineer Location: Raritan, NJ Duration: 6+ months Type: CON_W2 only NOTE: Pharma domain experience is mandatory.. Job description: Candidates with over 10+ years of experience as Data Engineer.Work closely with data scientists, analysts, and business stakeholders to understand data needsEnsure data quality, governance, and compliance with regulatory standards (e.g., GxP)Proficiency with SQL, Python, Spark, or related toolsExperience with cloud platforms (AWS, Azure, or Google Cl
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Posted 60+ days ago | Updated 1 day ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 29 days ago | Updated 4 hours ago

Global IT Compliance Sr Specialist

Thermo Fisher Scientific

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Pennsylvania, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 16 days ago | Updated 4 hours ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated moments ago

Lead Agile Coach

Intento Analytics LLC

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Remote

Contract

Skills required:Agile, Lead, Certification , GXP, compliance and Audit , Jira and Pharma industry Required Qualifications SAFe Certified professional with deep expertise in Apptio TargetProcess, Jira, and scaled agile delivery frameworks . Demonstrated knowledge of GxP-regulated projects in the pharmaceutical industry, ensuring compliance and audit readiness during Agile delivery. Skilled in the development and management of Objectives and Key Results (OKRs) to align program delivery with str
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Posted 7 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author 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
Posted 19 days ago | Updated 4 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 60+ days ago | Updated 4 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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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 4 hours ago

Infrastructure Business Analyst

TEKsystems c/o Allegis Group

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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 3 days ago | Updated 1 hour ago

Learning Management System (LMS) Administrator Specialist

Sunrise Systems, Inc.

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Lawrence Township, New Jersey, USA

Contract

Job Title: Learning Management System (LMS) Administrator Specialist Job ID: 25-08974 Location: Lawrence Township, NJ Duration: 05 months on W2 Contract Must Have List: B.S in education, science, or related discipline or equivalent experience.Minimum of 3+ years experience of ELMS, preferably SuccessFactorsMinimum of 3+ years experience in a training / learning organization / function3+ years of MS Office This position is responsible for the accurate and timely processing of all training re
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Posted 28 days ago | Updated 12 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 28 days ago | Updated 4 hours ago

Project Manager-Business Capability

HAYS

•

Princeton, New Jersey, USA

Contract

Project Manager-Business Capability - Contract - Princeton, NJ - $91.29 - $91.29/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 clie
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Posted 34 days ago | Updated 1 hour ago

Assoc. Director, PV Systems Reporting & Analytics

Sunrise Systems, Inc.

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Remote

Contract

Position Title: Assoc. Director, PV Systems Reporting & Analytics Job ID: 25-09090 Location: Remote Duration: 05 months on W2 Contract Top skills: Argus Safety application and drug safety domain knowledge, Computer Systems Validation & SDLC experienceStrong matrix management skills OBJECTIVE: Oversee and support tools used for the reporting and interactive analysis of data from the global pharmacovigilance (PV) databaseProvide technical and strategic input into the roadmap, planning, and imple
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Posted 21 days ago | Updated 12 hours ago