GxP Jobs

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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 40 days ago | Updated 1 day 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 47 days ago | Updated 1 hour 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 47 days ago | Updated 1 hour ago

SAP Integration Lead

ARK Infotech Spectrum

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Waltham, Massachusetts, USA

Contract, Third Party

Role: SAP Integration Lead Location : onsite (Waltham, MASSACHUSETTS) Job Description : Experienced SAP Integration Lead with deep expertise in designing and delivering robust, scalable, and compliant integration solutions within a pharmaceutical manufacturing environment. Strong technical leadership in SAP integration technologies (CPI, PI/PO, IDoc, APIs), coupled with a solid understanding of GxP, CFR 21 Part 11, and other regulatory requirements applicable to pharmaceutical operations. Key
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Posted 2 hours ago

Manufacturing IT Support Specialist @ Bridgewater/Somerville, NJ

Amzur Technologies, Inc.

•

Somerville, New Jersey, USA

Third Party, Contract

Manufacturing IT Support Specialist Location: Bridgewater/Somerville, NJ (100% on-site, Mon Fri) Duration: 12 months Experience Level: 8 10 years Key Responsibilities: Deliver daily IT support for systems in a life sciences manufacturing environmentProvide desktop and infrastructure troubleshootingSupport manufacturing-related systems: vision systems, automation tools, label printersCollaborate with on-site IT leadHandle incidents via ticketing system; follow ITIL frameworkAssist with test scrip
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Posted 3 days ago

Data Test Manager

Virtualan Software

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Boston, Massachusetts, USA

Full-time, Third Party

Title: Data Validation Test Lead onshore / onsite Location: Boston MA Duration: 12 Months Mode: Hybrid -onsite(3 Days Mandatory) Job Description: Experience in CSV, GxP, and regulatory standardsSkilled professional with a life science or pharmaceutical backgroundStrong knowledge on DWH ConceptsWorking experience on SnowflakeStrong Knowledge on Reports testing - UI and Data TestingStrong knowledge on Various data sources - Flat file, DB, API and othersStrong Knowledge on Various Target interactio
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Posted 5 days ago

IT Infrastructure Support Specialist

Geopaq Logic

•

Stollberg, Saxony, Germany

Contract

Position : IT Infrastructure & Shop Floor Specialist Location : Stollberg, Germany Duration : 6 + Months Key Responsibilities Perform routine maintenance, troubleshooting, and repairs of IT hardware (e.g., servers, workstations, shop floor devices) in compliance with regulatory standardsEnsure uptime of critical systems in a regulated (e.g., GxP, ISO) production environmentProvide onsite IT support for production equipment, resolving technical issues promptly to minimize downtimeCollaborate wi
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Posted 14 days ago | Updated 9 days ago

Lead Engineer MES Opcenter

Zettalogix INC

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Remote

Contract, Third Party

Position: Lead Engineer MES Opcenter RemoteDuration: 6 months with opportunity for extension or conversion Job Description:Lead Engineer MES OpCenter 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 via a third-party and through other client organizations to develop & deploy MES application software to Medical Device manufacturing s
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Posted 4 days ago

Clinical Supplies Project Manager | 100% Remote | Contract

Alpha Business Solutions LLC

•

Remote or Cambridge, Massachusetts, USA

Contract

Our direct end-client a large R&D focused global pharma client is seeking to hire for the position of Clinical Supplies Project Manager. Job Title: Clinical Supplies Project Manager Location : Remote (EST) Duration: 6-12 months plus (possible long term) Pay rate: $80/HR - $100/HR (negotiable) Job Description We are seeking a highly motivated Project Manager with extensive experience managing GxP-compliant project. The ideal candidate will excel in handling multiple workstreams, collaborating wi
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Posted 4 days ago | Updated moments ago

Veeva Vault PromoMats Tech Lead

TeamSuccess LLC DBA HiEd Success

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Remote

Contract

Veeva Vault PromoMats Tech Lead Work location: Chicago, IL Work remotely: Yes Required skills: Self-starter that can lead colleagues and customers through complexity to get results.Additional Veeva certifications.Additional experience in the following technical disciplines: Data Warehousing, Web Services, ETL, SQL, Force.com, FTP, and Batch CSV integrations, and data migrations.Experience with other relevant technologies and integration patterns such as Salesforce and IQVIA.Familiarity with heal
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Posted 12 days ago | Updated 6 days ago

Veeva Solution Architect

Stanley David and Associates

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Remote

Full-time

Must Have Technical/Functional Skills Deep and strong experience with Veeva Vault (Quality) configuration and implementation.Should have data migration experience in Veeva Vault.Should have Integration experience with Veeva Vault.Should have Veeva Rest API and SDK experience.Must have Python or Java experienceMust be able to handle all queries / issues from offshore during crisisUnderstanding of SaaS/Cloud solutions and technologyGood communication skillMust have clear understanding of Veeva Vau
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Posted 20 days 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 47 days ago | Updated 1 hour 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) w
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Posted 18 days ago | Updated moments ago

Biomanufacturing Material Handler

SGS Consulting

•

Durham, North Carolina, USA

Contract

Job Title: Material Handler II Duration: 06 Months+ (Contract to Hire) Location: Durham (RTP), NC 27709 Schedule: Monday - Friday 8am - 5pm_minimal overtime MUST HAVE A TRUE UNDERSTANDING OF WORKING IN A cGMP WAREHOUSE ** Cross training opportunity in Dispensary Biomanufacturing ** Job Description: In support of manufacturing, the material handler will receive raw materials, process manufacturing orders, weigh and dispense activities, and shipping of final drug substance.The role is focused on
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Posted 14 days ago

MES Implementation Consultant

Voto Consulting LLC

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Princeton, New Jersey, USA

Full-time

Role- MES Implementation Consultant Location: Princeton, NJ (Hybrid) Duration:: 2-3 Years Visa- NO OPT & H1B Description Our client is a global technology company, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. Our client works across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom
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Posted 4 days ago

Argus SME

Intone Networks Inc.

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Raleigh, North Carolina, USA

Third Party, Contract

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

Information Security & Risk Management (ISRM) Analyst

The Fountain Group

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Remote

Full-time, Contract

Pay: $75-$80We are a national staffing firm and are currently seeking an Information Security & Risk Management (ISRM) Analyst for a prominent client of ours. Details for the position are as follows: Job Description: Conduct and manage cybersecurity risk assessments of pharmaceutical applications and supporting technologies, staying ahead of evolving threat landscapes. Design, implement, and validate cybersecurity controls throughout the application development lifecycle. Identify application se
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Posted 3 days ago | Updated moments ago

Technical Writer II

HireTalent - Staffing & Recruiting Firm

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Swiftwater, Pennsylvania, USA

Full-time

Job DescriptionJob Title: Technical Writer II Location: Swiftwater, PA- 18370 Duration: 6-month contract Responsibilities: Responsible for designing, developing, and updating required technical documentation.Responsible for technical writing/editing for all types of documentation produced within a modern software development environment.Utilize knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.Document programming sta
Posted 2 days ago | Updated 22 hours ago

CSV CONSULTANT :: Remote

TESTINGXPERTS, INC. DBA DAMCOSOFT

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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
Easy Apply
Posted 53 days ago | Updated 2 hours ago

Engineer III, Validation

Thermo Fisher Scientific

•

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 12 hours ago | Updated 1 hour ago