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GxP Business Analyst/Project Manager

Eliassen Group

•

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 9 days ago | Updated 3 hours ago

Benchling Technical Support Specialist (GxP / CSV Experience Preferred)

Infinite Computer Solutions (ICS)

•

Remote

Third Party, Contract

Job Summary: We are seeking a skilled and proactive Technical Support Specialist with hands-on experience supporting Benchling, a leading cloud-based platform for life sciences R&D. The ideal candidate will have a strong background in providing technical application support within a regulated GxP environment, and exposure to Computer System Validation (CSV) is highly desirable. The role requires close collaboration with the client s IT and Quality teams to ensure consistent and compliant system
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Posted 29 days ago

GXP Validation Engineer

Katalyst Healthcares and Lifesciences

•

Boca Raton, Florida, USA

Full-time

Responsibilities: 12 years' Experience in Validating systems and Experienced in GxP related applications. Perform review for GxP systems to ensure compliance with regulatory requirements as per the customer SOPs. Expertise on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology. Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test scr
Posted 16 days ago | Updated 3 hours ago

GxP Lab Computing Engineer

Katalyst Healthcares and Lifesciences

•

Albany, New York, USA

Full-time

Job Description: The Lab Computing Engineer provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal support team. Responsibi
Posted 16 days ago | Updated 3 hours ago

Validation Test Lead

Nexo Global Inc.

•

King of Prussia, Pennsylvania, USA

Contract

Role - Validation Test Lead Location - USA King of Prussia(Hybrid) Job Details: 10 years Experience in Validating systems and Experienced in GxP related applications. Perform review for GxP systems to ensure compliance with regulatory requirements as per the customer SOPs.Expertise on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology.Requirement Specifications, Functional Specifications/ User Stories
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Posted 2 days ago

Data Integrity Manager

LanceSoft Inc.

•

New Brunswick, New Jersey, USA

Contract

Summary: The position is located in the Global Quality GxP IT Quality Assurance department within the Data Integrity tower.It is responsible for providing support to the Lead of the GxP Data Integrity program across the end-to-end product lifecycle, ensuring that regulatory and CLIENT requirements are thoroughly and effectively addressed promptly. Key Responsibilities and Major Duties: Provide oversight for the governance, management, and coordination of activities related to the Data Integrity
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Posted 8 days ago

Senior Technical Product Owner Pharma Domain

AspireIT Solutions

•

Texas, USA

Full-time, Contract, Third Party

Aspire IT Solutions is hiring Job Title: Senior Technical Product Owner Pharma Domain Location: Remote (Must reside in EST or CST time zones) Type: Contract Overview: We're seeking a Senior Technical Product Owner with strong pharma industry experience to lead digital product delivery in a regulated environment. You'll bridge business and technical teams, ensuring compliant and scalable solutions that meet pharma standards. Key Responsibilities: Define and manage product roadmap, backlog, a
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Posted 11 days ago | Updated 8 hours ago

PharmaSuite MES - Concord or Indianapolis, NC (Remote)

The Brixton Group

•

Remote

Contract, Third Party

Job Title: PharmaSuite MES Location: Concord or Indianapolis, NC (Remote) Duration: 12 months PharmaSuite MES Onsite Tier 2 Support Career level 3+ Design/Author/Develop/Configure Electronic Batch Records (EBR), following GxP and SDLC protocols Implement MES solutions and integrate with ERP and control equipment Documentation of MES configuration and validation of EBRs Gather user requirements in relation to controlling and recording manufacturing activities Collaborate with business to define
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Posted 16 days ago | Updated 8 days ago

SAP QM Functional Consultant

Devfi

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Remote

Contract

Position Title: SAP QM Functional Consultant Location: Foster City, CA Duration: 6 Months Required Skills: Need a seasoned SAP QM Functional resource with good experience in Life Science industry (Pharma, Biotech, Med Devices, etc.)Someone who has great functional knowledge of core QM functions in S/4HANABatch Management: Derivation, Genealogy, Determination, Classes, Characteristics, SLED, etc.Good understanding of QM integration with supply chain and logistics modules (MM, IM, EWM, etc.)Requi
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Posted 7 days ago | Updated 5 hours ago

Senior Engineer

Katalyst Healthcares and Lifesciences

•

Round Lake, Illinois, USA

Full-time

Responsibilities: Under direction of supervisor or the sterility assurance focal point, contributes to the design, development or enhancement of new products and processes. Effectively contribute solid technical knowledge to a variety of projects within the sterility assurance discipline with minimal assistance. Display basic technical understanding of related sterility assurance disciplines, specifically sterilization modalities. Utilize engineering tools to solve straightforward problems.
Posted 16 days ago | Updated 3 hours ago

Enterprise Solutions Architect

NTT DATA Americas, Inc

•

Pittsburgh, Pennsylvania, USA

Contract

NTT DATA's Client is seeking an Enterprise Solutions Architect to join their team REMOTE. * Directly lead and manage teams focused on delivering high quality project results within one or more major technology disciplines: strategy, data management, cloud optimization, operations, engineering, information security, privacy, compliance, change management and stakeholder relationships. * Focus on team leadership, delivery of business value, risk mitigation, cost optimization and return on investme
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Posted 14 days ago | Updated moments ago

Argus SME

Intone Networks Inc.

•

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 5 hours ago

Lab Computing Analyst

Pyramid Consulting, Inc.

•

Lansdale, Pennsylvania, USA

Contract

Immediate need for a talented Lab Computing Analyst. This is a 06+months contract opportunity with long-term potential and is located in Lansdale, PA(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 25-72571 Pay Range: $32 - $33.75/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Shift timings-40 HR/wk, M-F,
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Posted 2 days ago

CSV CONSULTANT :: Remote

TESTINGXPERTS, INC. DBA DAMCOSOFT

•

New Jersey, USA

Contract, Third Party

Mandatory Skills CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ), Veeva, Argus, Defect Tracking Tools_JIRA Primary Skill- Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management Secondary Skill- JIRA Veeva Argus Agile and Waterfall methodology Jo Description: Strong experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems P
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Posted 22 days ago | Updated 20 hours ago

Oracle EBS (PTD, SCM) Techno-Functional Consultant

NexInfo Solutions, Inc.

•

Frederick, Maryland, USA

Third Party, Contract

The consultant should be 50-50 Techno-functional.Must have a clear understanding and expertise in PTD Plan to Deliver process.This includes Planning materials and production, Moving materials into Inventory, the Pharma QA process, Shipping the materials, and the Logistics understanding of shipping (transportation).Must have GXP knowledge.Pharma / Life Science experience is highly preferred.Thanks, Infant Selvin NexInfo
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Posted 39 days ago | Updated 2 days ago

PharmaSuite MES Consultant

Collabera LLC

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Concord, North Carolina, USA

Full-time

One of our Direct Client looking for PharmaSuite MES Consultant JOB DETAILS Title: PharmaSuite MES Support Consultant Location: Concord NC, Indianapolis IN & 100% Remote Duration: 12 months Pay Range : $65-67/hr Please email me at to speak in detail about the job. Top Skills : PharmaSuite MES Consultant, PharmaSuite MES Support Consultant, PharmaSuite MES, PharmaSuite , Manufacturing IT Support , PharmaSuite authoring, Manufacturing Execution Systems (MES), Electronic Batch Records (EBR) ,
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Posted 8 days ago | Updated 2 hours ago

MES (Manufacturing Execution Systems) Engineer

Comrise

•

Lake Forest, California, USA

Third Party, Contract

As an MES Engineer, you will be part of a team responsible for the implementation, support, and optimization of our Manufacturing Execution System (MES). You will work closely with cross-functional teams to ensure the MES aligns with production goals, improves efficiency, and supports our commitment to quality and operational excellence. Key Responsibilities: Provide technical support and training to manufacturing personnel on the use of the MES.Monitor system performance and identify opportunit
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Posted 57 days ago | Updated 31 days ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Raritan, New Jersey, USA

Full-time

Responsibilities: This resource will support the following related to our Service Industrialization (SI) project Review the Services SI excel spreadsheets for tools, applications and other technologies required to provide the service. There are about 21 spreadsheets Design and set up Mapping Structure for TS Services in SharePoint List Record the technologies from the excel spreadsheets in the Mapping Structure for each Service. Collect the CMDB information for each technology pulled from the sp
Posted 11 days ago | Updated 3 hours ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

•

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 52 days ago | Updated moments ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Waltham, Massachusetts, USA

Full-time

Responsibilities: Independently perform validation activities including installation qualification, operational qualification, performance qualification for Base Camp projects related to facility, utilities, equipment and instrument. Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution. Ensure deliverables meet the overall facility milestones. Perform and support periodic assessment review and revalidation activities. Ensure deliv
Posted 16 days ago | Updated 3 hours ago