gxp Jobs in north carolina

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Solution Architect - Serialization SAP S4 HANA ATTP & Warehouse (Remote) :: Collegeville, PA

DMS Vision Inc.

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Remote or Arkansas, USA

Contract

Hi, Hope you are doing well, Please find the job description given below and let me know your interest. Position: Solution Architect - Serialization SAP S/4 HANA ATTP & Warehouse (Remote) Location: Collegeville, PA ( Occasional travel required) Duration : 5 months Job Description: Required Skills Roles and Responsibility: - Ideal candidates have deep working Knowledge of global pharma industry standards/guidelines to enable serialization for manufacturing and logistics as a solution ar
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Posted 8 hours ago | Updated 2 hours ago

Enterprise MDM Data Governance Lead

MANDO TECHNOLOGIES INC

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Remote

Full-time, Contract

At Mando Technologies, we specialize in helping organizations unlock the full value of their data. From acquiring and organizing information to analyzing and delivering insights and ultimately integrating that intelligence into day-to-day operations we support the entire Business Intelligence journey from start to finish.Job Title: Enterprise MDM Data Governance Lead Employment Type: 1-Year Contract (Intent to convert to FTE) Top Priorities: In-House Ownership: Must have deep client-side (non-c
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Posted 1 day ago | Updated moments ago

IT CSV Manager

4A IT Services LLC

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Durham, North Carolina, USA

Contract, Third Party

We are seeking an experienced and highly motivated CSV Implementation Lead to drive the successful deployment and integration of enterprise systems including Dynamics 365, LIMS, POMS, MES, and other automation and data management platforms at a major life sciences/biotech site in the Raleigh, NC area. This is a 100% onsite role with a strong emphasis on leadership, mentoring, and capability-building of internal teams, reporting directly to the CSV/QA Manager. Required Skills & Qualifications: Mi
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Posted 6 hours ago | Updated 1 hour 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 37 days ago | Updated 2 hours 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 37 days ago | Updated 8 hours ago

Argus SME

Intone Networks Inc.

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Raleigh, North Carolina, USA

Contract, Third Party

Job Title - Argus SME Location - Raleigh, NC Hire Type -Contract Job description: 10 12+ years of IT experience in the Life Science Area Good domain knowledge in PV Argus Configuration/customization Argus Support as per ITIL process Hands-on experience in GxP Application support and Enhancement Must-Have: Knowledge of CSV process for Pharma Years of Experience: 12.00 Years of Experience
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Posted 60+ days ago | Updated moments ago

Compliance Lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 6 days ago | Updated 1 day ago

Remote Consulting Project Manager - SAP Supply Chain Management (Pharmaceutical Industry)

Business and Technology Solutions, LLC

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Remote

Contract

Our client is seeking a remote Consulting Project Manager, initially on a fractional basis (~15-20 hours weekly), with SAP Supply Chain Management experience within the Pharmaceutical industry. The initial length of assignment will be 6 months to start, with potential for one or multiple extensions. The Consulting Project Manager will be responsible for, but not limited to, the following: Act as the Project Manager for the SAP SCM implementation from inception to go live and post production su
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Posted 2 days ago | Updated 1 day 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 29 days ago | Updated 9 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 9 days 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

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 14 days ago | Updated moments ago

Principal Web Applications Engineer

Johnson & Johnson

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Remote or Santa Clara, California, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 2 hours ago

MedTech Transcend Release Train Engineer

Johnson & Johnson

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Remote or Raritan, New Jersey, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 3 days ago | Updated 2 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 36 days ago | Updated 2 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 27 days ago | Updated 2 hours ago

Senior IT Compliance Engineer - FFEx

Novo Nordisk Inc

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Clayton, North Carolina, USA

Full-time

About the Department You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk's 50,000 employees. FFEx is a newly established and growing area with the responsibility to design, plan, and buil
Posted 26 days ago | Updated 2 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 2 hours ago

Data Engineer III - ET SDF

Novo Nordisk Inc

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Durham, North Carolina, USA

Full-time

About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and or
Posted 31 days ago | Updated 2 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 25 days ago | Updated 2 hours ago