GxP jobs

Hybrid in Philadelphia, Pennsylvania

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8d ago

Lab Support Engineer Location- Philadelphia, PA 12+ Months Skills- GMP / GxP Mandatory JD can be used for both roles. Background with End-user Computing or Desktop Support skills essential. Break/Fix consists of 80% of a Lab Engineer S workload Scientist interaction Implement the validated data backup solution on laboratory analytical equipment (equipment and software investigation, documentation, technical configuration) within R&D (GxP and non-GxP) Knowledge and understanding of Active Direct

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Contract

Depends on Experience

GxP Compliance Lead

Lansdale, Pennsylvania

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Today

Location: Lansdale, PA Description: Job Title: GxP Compliance Lead Location: West Point, PA (Hybrid - 3 days onsite per week) Employment Type: Contract (12 months with possible extension) Compensation: 50-55/hr W2 only - Must be able to accept work without sponsorship now or in the future. About the Role: We are seeking a GxP Compliance Lead to provide quality oversight for GxP computerized systems and ensure compliance with company policies, procedures, and regulatory expectations.

Contract

USD 50.00 - 55.00 per hour

GXP APPLICATION SUPPORT TECH LEAD

Hybrid in Boston, Massachusetts

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5d ago

Immediate need for a talented GXP APPLICATION SUPPORT TECH LEAD. This is a 06+ months contract opportunity with long-term potential and is located in Boston, MA (Hybrid). Please review the job description below and contact me ASAP if you are interested. Job ID: 25-91456 Pay Range: $90 - $100/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: Support and maintain

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Contract

$90 - $100

GMP & GxP Business Analyst

Remote

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Yesterday

GMP & GxP Business AnalystLocation: RemoteDuration: Long Term Roles & ResponsibilitiesGather, analyze, and document business and user requirements across functional teams.Act as the primary liaison between Business, IT, end users, and cross-functional stakeholders during project execution and maintenance phases.Analyze business challenges and support evaluation of appropriate IT solutions.Collaborate with managers and end users to ensure alignment and buy-in for proposed solutions.Develop detail

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Contract

Depends on Experience

GxP Test Lead

Remote

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5d ago

Primary & Secondary Skill P :GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain. JD (Detailed) 15+ yearsof software QA/testing experience, with at least10+ yearsin regulated environments like life sciences, pharma, healthcare. Strong expertise inGxP compliance,CSV, andFDA 21 CFR Part 11standards. Strong leadership, test planning, estimation, and cross-functional communication skills. Experience in testingSAAS/COTS/Bespoke,CRM,Life sciences systems, orlab systems(e.g.,St

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Contract

60 - 65

GMP & GxP Business Analyst

Remote

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2d ago

Role : GMP & GxP Business Analyst Location : Remote W2 OnlyNote: Must have Pharmaceutical or Healthcare ExperienceRoles & Responsibilities: Collect data, analyse & define the business and user requirementsPoint of contact and between business, IT, end user and other cross functional teams during the project or maintenance phase.Analyse business problems and facilitate in IT solution evaluation.Work closely with managers and end users to have buy-in for the proposed solution.Creating a detailed

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Contract

Depends on Experience

GXP / GMP Data Integration Engineer

Vacaville, California

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2d ago

Senior Data Integration Engineer Location: Vacaville, CA Duration: - 6-12 Months+ Company: A leading organization in the Biotech, Pharma, or Healthcare IT sector. About the Role: We are seeking a highly skilled and analytical Senior Data Integration Engineer to play a pivotal role in architecting and delivering high-impact data solutions. This position is ideal for a professional who excels at bridging technical execution with strategic project leadership. You will be responsible for leading the

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Contract

Depends on Experience

GXP Instrument Systems Engineer

Norwood, Massachusetts

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Today

Job Description: The qualified GxP Instrument Systems Engineer / Senior Project Engineer will be responsible for the design, deployment and management of automation and digital enterprise instrumentation systems that support Quality Control laboratories and system integration with connected Digital platforms. Responsibilities: Collaborate with Business Analysts and Software/Automation Engineers in the complete product lifecycle management of Digital Quality Automation Systems (Hamilton Venus, W

Full-time

GxP Lab Computing Engineer

Chicago, Illinois

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Today

Required Skills: Excellent customer service skills complemented by an ability to listen to and interpret client requests Ability to troubleshoot complex instrument and technology issues Strong oral and written communication skills Ability to identify, track and complete tasks for multiple projects Knowledge of laboratory safety practices as defined by the company and/or customer's site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsib

Full-time

Validation Engineer - GxP Systems

San Francisco, California

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Today

Responsibilities: Lead and manage CSV (Computer System Validation) for GxP systems across Quality, Manufacturing, Clinical, and Business areas. Develop and maintain validation procedures, templates, and master validation plans. Prepare and review validation documentation (plans, protocols, reports). Ensure compliance with GAMP 5, 21 CFR Part 11, and ISO 13485. Collaborate with cross-functional teams (IT, QA, Engineering, Manufacturing, Clinical). Support change control, audits, CAPA, and documen

Full-time

SAP PPQM PTS Consultant Remote

Remote or Atlanta, Georgia

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Today

Job Id: #CGEMJP00321513 Title: SAP PPQM PTS Consultant Location: Remote Duration: 12+ Months Position Summary: Job Role and Responsibilities: We are looking for a highly skilled Senior SAP PPQM Consultant with over 6 years of experience in SAP Production Planning (PP) and Quality Management (QM) modules, specifically within the pharmaceutical industry. The ideal candidate will have a deep understanding of GxP compliance, regulatory requirements, and validation documentation. This role involv

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Full-time, Part-time, Third Party, Contract

Technical Writer - Pharma IT Compliance

Remote

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9d ago

Position Summary - The Technical Writer will be responsible for developing, maintaining, and improving IT process documentation within a regulated pharmaceutical (GxP) environment. This role involves authoring and managing key compliance documents, supporting infrastructure qualification activities, and ensuring alignment with global IT standards and QA expectations. The individual will work closely with project teams, IT compliance, and global shared services to ensure adherence to regulatory

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Contract, Third Party

Depends on Experience

IT SOX Analyst

Alameda, California

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6d ago

Job Description: Create the product vision, customer persona identification, product framework for IT's compliance practices including the scopes of SOX and GxPOur client is a public biopharmaceutical company that is regulated by different governmental agencies. It is important that IT operates in a manner that is consistent, accurate, and high quality so that they stay in compliance with GxP and SOX procedures, protocols and audits. This role collaborates with IT members, QA leadership, Finance

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Contract

70 - 75

Project Manager Regulated Systems (Veeva Implementation)

Remote

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Today

Job Title: Project Manager Regulated Systems (Veeva Implementation) Position Summary We are seeking an experienced Project Manager with a strong background in regulated systems and vendor/IT coordination to lead the implementation and enhancement of Veeva applications (Vault QMS, RIM, QualityDocs, etc.). The ideal candidate will have demonstrated success managing projects in GxP-regulated environments, ensuring compliance, alignment with business objectives, and timely delivery of system soluti

Contract, Third Party

CSA Auditor, TraceLink

Remote

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8d ago

We are seeking a Computerized System Assurance (CSA) Auditor with deep experience in TraceLink and GxP-regulated environments to ensure the compliance, validation, and lifecycle integrity of computerized systems supporting serialization, traceability, and supply chain management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory expectations for data integrity and system validation. Key Responsibilities: Plan, conduct, and report CSA aud

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Contract

85 - 90

IT Support Engineer

Hybrid in Palo Alto, California

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6d ago

Sr. IT Support Engineer L2 experience, White Glove supportWindows & MacOS administrationLife Sciences GxP FDA compliance experienceCloud (AWS Azure)Identity Management (Okta, AD)Networking - MerakiEndpoint Management (Intune, Exchange, SentinelOne, Zscaler)\PowershellLet me know if you have any additional questions, Job Description: Sr. IT Support EngineerLocation : 3160 Porter Drive, Suite 250 Palo Alto, CA. 94304 Who You AreWe are looking for a Sr. IT Support Engineer who thrives in a hands-

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Contract

Depends on Experience

Empower CDS administration / support

Greenfield, Indiana

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29d ago

Job Title: Empower CDS administration/ supportLocation: Greenfield, INDuration: Long term contract/Full time Open Educational Qualification*Any Bachelor's DegreeExperience Range8-10 yearsPrimary (Must have skills)* - To be Screened by TA Team3+ years of hands-on experience in Empower CDS administration and support. 3+ years of experience on HPLC/UPLC and other analytical instrument integration. 3+ years of experience on Computer System Validation (CSV) and preparation of validation deliverable

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Third Party, Contract

Depends on Experience

Clinical Business Analyst

Remote

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Today

Clinical Business Analyst Job Summary: The Business Analyst, Clinical Data & Integrations, will be a key liaison between business stakeholders and technical teams, focusing on understanding, documenting, and optimizing data flows for clinical trial systems and external data sources. This role is critical for ensuring that data integrations are robust, well-defined, and support the organization's analytical and operational needs, with a strong emphasis on facilitating data governance 3+ years of

Third Party, Contract

SAP Validation Consultant

No location provided

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Today

Position: SAP Validation Consultant Location/ Travel Onsite Requirements 100% remote Responsibilities: Lead GxP validation efforts for the SAP S4 HANA system, ensuring compliance with industry regulations and standards Develop and execute validation plans, protocols, and reports to document compliance and system performance Collaborate with cross-functional teams to identify validation requirements and ensure alignment with business objectives Provide expert guidance and support during audi

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Full-time, Third Party, Contract

CSV Lead Consultant

Hybrid in South San Francisco, California

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5d ago

Position: CSV Lead Consultant Location: South San Francisco, CA (Hybrid, 3 days/week onsite) Position type: 12+ Months (with possible extension) Job description: This is a hybrid role for a CSV Lead, located in South San Francisco, CA with some flexibility for remote work. The individual will oversee computerized system validation efforts, ensuring compliance with regulatory and quality standards. Key tasks include planning, developing, and executing validation strategies for systems such as

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Contract, Third Party

Depends on Experience

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