GXP jobs

Highland Heights, Kentucky

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Today

Hello, Hope you are doing well, GxP Validation Analyst Job Location:-Highland Heights, KY (Day 1 Onsite, Candidate needs to work 5 Days at the Client Office) Project Overview Global Instrument Software Validation Project covering 200 unique instruments. Scope includes: Documenting and validating software installed on lab instrumentation per EMA guidelines Migrating and adherence of instrument software management to PPD IT SOPs Capturing requirements, configurations, and compliance documentati

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Contract, Third Party

GxP Instrument Systems Engineer

Hybrid in Norwood, Massachusetts

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4d ago

Position: GxP Instrument Systems Engineer Location: Norwood, MA (Hybrid Model) Job Type: Contract long-term Job Description: The GxP Instrument Systems Engineer / Senior Project Engineer will lead the design, deployment, and management of automation and digital enterprise instrumentation systems supporting Quality Control laboratories and integration with connected digital platforms. Required Qualifications: Bachelor s degree in science, engineering, or computer science (or equivalent).5 7+ year

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Contract, Third Party

Depends on Experience

GxP Instrument Systems Engineer

Marlborough, Massachusetts

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Today

TITLE- - GxP Instrument Systems Engineer / Senior Project Engineer Location - Ability to be on-site 3-4 days/week between Marlborough, MA and Norwood, MA locations Long Term Contract 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. Job Responsibiliti

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Contract, Third Party

$market rate

Senior Project Manager (Strong GxP compliance)

Hybrid in Jersey City, New Jersey

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22d ago

Job Description:We are seeking a highly experienced Senior Project Manager to lead and deliver critical projects within a regulated environment. The ideal candidate will have strong expertise in GxP compliance, project planning, release management, and waterfall methodologies. This role requires a proven leader who can work closely with cross-functional teams to ensure timely, high-quality delivery. Key Responsibilities:Lead end-to-end project lifecycle from initiation through closure. Develop a

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Contract

$50 - $60

GxP Validation Analyst With Technical Writers

Highland Heights, Kentucky

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2d ago

GxP Validation Analyst Job Location:-Highland Heights, KY (Day 1 Onsite, Candidate needs to work 5 Days at the Client Office) Note:- there is no client interview for this requirement, Project Overview Global Instrument Software Validation Project covering 200 unique instruments. Scope includes: Documenting and validating software installed on lab instrumentation per EMA guidelines Migrating and adherence of instrument software management to PPD IT SOPs Capturing requirements, configurations, an

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Contract

Depends on Experience

GxP Validation Analyst

Highland Heights, Kentucky

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2d ago

Title: GxP Validation Analyst Location:- Highland Heights, KY - Day 1 Onsite Duration: 6+MonthsExp: 9 Key Responsibilities Gather and document requirements (URS, software configuration) Write and execute validation test cases (IQ, OQ, PQ as applicable) Support to prepare requirements specifications, infrastructure & data flow diagrams Perform risk assessments and ensure traceability of requirements risks tests results Support SOP migration and alignment with PPD IT practices Communicate effectiv

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Third Party, Contract

Depends on Experience

Salesforce Director with GxP

Remote

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4d ago

Required Skills: Bachelors or Masters degree in Computer Science, Information Systems, or related field.12+ years of experience in Salesforce ecosystem, with at least 5+ years in leadership roles (Director/Program Manager/Enterprise Architect).Strong background in hospitality domain systems (loyalty, reservations, PMS, CRS, guest engagement).Proven expertise in Mpower platform integration with Salesforce.Deep understanding of GxP compliance, IT SOX controls, and system validation processes.Direc

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Contract

$80 - $90

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

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

Remote

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2d 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

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

Senior Quality, Document Specialist

Boston, Massachusetts

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Yesterday

Position: Senior Quality, Document Specialist Location: Boston, MA Job Type: Contract Duration: 6 months to start Job Description: The Senior Document Control Specialist is responsible for overseeing the management, organization, and maintenance of all controlled documents within the company s quality management system (QMS). This role ensures compliance with regulatory requirements, company policies, and industry standards, supporting the efficient operation of the pharmaceutical development

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Contract

Depends on Experience

SDMS System Administrator

Remote

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14d ago

Role: System Administrator Location: NEAR SHORE - South America/Canada Length: Long term rolling contract Job Description: -Able to provide Waters NuGenesis SDMS technical support in a GMP regulated environment. -General working knowledge of laboratory testing processes and automation using NuGenesis SDMS -Responsibilities include but not limited to: -Provide Level 3 (L3) technical expertise in identifying, evaluating, and developing SDMS and procedures that l-leverage system capabilities and m

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Contract

$25 - $35

Clinical Program Manager Healthcare

Raritan, New Jersey

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Today

Clinical Program Manager Healthcare Location : Raritan, NJ Duration : Long Term Job Description: Delivery experience of large programs having multiple projects Functional knowledge of various global drug development clinical testing business. Should be able to guide POs Able to map business needs to solutions in global drug development Have technical background. Worked as Tech Architect Comfortable in leading technical architecture and design discussions with client in Full Stack MEAN, Gen

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

$DOE

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, Contract, Third Party

Pharma Regulatory Technical Program Lead

Raritan, New Jersey

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Today

Technical Program Lead Location: New Jersey (Onsite) Duration: Full time. Required Experience : 10+ Years required . Pharma Regulatory Technical program lead NJ USA Delivery experience of large programs having multiple projects Functional knowledge of various Pharma Regulatory business. Knowledge of COTS products. Should be able to guide POs Have technical background. Worked as Tech Architect Comfortable in leading technical architecture and design discussions with client in Full Stack MERN, G

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

$DOE

IT System Engineer

Boulder, Colorado

•

Yesterday

Description: TOP SKILLS PER MGR: Experience in managing IT-OT setup for labs and production facilitiesOnce onboarded, must learn the compliance requirements and implement themBasic understanding of IT network and security PURPOSE As an Advanced/OT Operation & Infrastructure Professional, you will serve as the first point of contact for the Boulder site regarding any IT equipment or IT system related issues. You will collaborate with suppliers and global teams to resolve these issues efficientl

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Contract

Depends on Experience

Computer System Validation Engineer

Hybrid in Raritan, New Jersey

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18d 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

Test Engineer - Pharma Compliance (Life sciences exp)

Remote

•

Today

Test Engineer - Pharma Compliance (Life sciences exp is required) Expert in testing, validation and compliance. - Min 5 Yrs Experience in GMP validation of QA analytics applications. - Min 3 Experience on using Tricentis qTest, Vera, and JIRA - Technical background in Full Stack technology for both front-end and back-end - Strong experience with data visualizations technology such as React, Angular, Javascript - Strong understanding of GxP and regulatory standards in pharmaceutical industry. -

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Third Party, Contract

$40,000 - $46

Program Leader (Strategy & Transformation)

Jersey City, New Jersey

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5d ago

Program Leader (Strategy & Transformation) Location: New Jersey (Candidates in and around Nj within commutable distance) Full Time Visa: No H1B Seeking a highly accomplished Program Leader (Strategy & Transformation) with deep expertise in the Healthcare and Pharmaceutical sector. The ideal candidate will bring a blend of management consulting rigor and industry leadership experience, with proven success in driving large-scale business transformations, strategic initiatives, mergers & acquisiti

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Full-time

Depends on Experience

SAP OTC Business Analyst-Netsuite to SAP S4 HANA Migration

No location provided

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Today

SAP Sales & Distribution Order to Cash Inventory, Gross-to-Net (GTN), Ex-Factory SP SD Pricing & Rebates, 3PL/CMO operations (Make/Pick/Pack/Ship, product delivery, invoicing). S4 HANA experience in OTC domain SAP Implementation experience(Configuration, testing & troubleshooting) NetSuite to SAP S/4HANA migration is a plus. Life sciences regulations (GxP, 21 CFR Part 11) is a plus. Prior experience with pharmaceutical companies

Contract

Depends on Experience

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