21 cfr part 11 jobs in baltimore, md

Remote

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Yesterday

We are seeking a Senior IT Project Manager with demonstrated experience leading complex, cross-functional technology initiatives in global and regulated manufacturing environments. The immediate priority for this role will be the delivery of projects involving Manufacturing Execution Systems, with a primary focus on the Critical Manufacturing MES platform. The successful candidate should also bring experience that can be applied across adjacent enterprise technology domains, such as SAP/ERP,

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Contract

60 - 65

Lead Bioinformatics Engineer

Baltimore, Maryland

•

Today

Job Description Pay Range: $130,000.00 - $160,000.00 / year Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation. Benefits Information: We are proud to offer best-in-class benefits and programs to support employees and their families in living heal

Full-time

USD 130,000.00 per year

MES Project Manager

Remote

•

Yesterday

Managing, planning and execution of complex global IT projects across manufacturing and enterprise application domains, with an immediate focus on Critical Manufacturing MES initiatives. Coordinate integrations between MES and adjacent platforms, including SAP/ERP, Quality Systems, PLM, warehouse applications, automation solutions, and data platforms. Oversee validation planning and compliance deliverables in accordance with applicable FDA, GxP, and 21 CFR Part 11 requirements. Coordinate cross-

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Third Party, Contract

Depends on Experience

Lead LIMS Developer (SAPIO/LabVantage & Java)

Remote

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3d ago

Lead LIMS Developer (SAPIO/LabVantage & Java)Remote Full Time OverviewLead the architecture, development, and modernization of enterprise LIMS platforms using SAPIO/LabVantage, Java, and cloud technologies. Partner with laboratory and healthcare stakeholders to deliver scalable, secure, and compliant solutions. Key Responsibilities Lead architecture, design, development, and implementation of SAPIO LIMS and/or LabVantage.Translate laboratory requirements into workflows, integrations, and data mo

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Full-time

Depends on Experience

Project Manager – MES

Remote

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2d ago

8+ years of IT Project Management experience leading medium-to-large global implementations, upgrades, and transformation projects.Manufacturing Execution Systems (MES) experience is required, preferably Critical Manufacturing, with experience in MES deployments, rollouts, upgrades, integrations, or multi-site initiatives.Strong experience managing cross-functional global teams, project plans, budgets, resources, RAID logs, risks, issues, dependencies, and executive reporting.Experience in regul

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Full-time

50 - 60

Principal LIMS Developer

Remote

•

2d ago

Hello, Job Title: Lead LIMS Developer (SAPIO/LabVantage & Java) Overview Lead the technical direction of a major Laboratory Information Management System (LIMS) modernization initiative focused on designing and delivering a future-state laboratory platform. This role combines architecture, hands-on development, technical leadership, and close collaboration with laboratory and healthcare stakeholders to build scalable, compliant LIMS solutions. What You'll Do Lead the design, architecture, and im

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Contract, Third Party

$65 - $70

Life Science Business Analyst with Project Management (BA/PM) -- Veeva Vault, GxP

Remote

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2d ago

Job Role: Business Analyst with Project Management (BA/PM) Location: Cambridge MA - Remote Mode: Long Term Project Job Required: We need emphasize on Gxp, CRO, Biotech, change requests, requirement traceability matirx, decommisioning applications, small projects , vendor management and stake holder management.10+ years of combined experience in Life Sciences IT, including:Minimum 5 years in a GxP-regulated system administrator or support capacity.Minimum 5 years in project management, delivering

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Contract

Depends on Experience

DeltaV Training Developer & Instructor

Remote

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3d ago

Position Overview: Develop and deliver a structured, Good Manufacturing Practice (GMP)-aligned DeltaV v16 Long-Term Support (LTS) training program for automation engineers and cross-functional stakeholders at a greenfield pharmaceutical manufacturing facility. Create site-specific learning content using the customers actual configuration, equipment, recipes, and DeltaV Live graphics. Deliver hands-on training in a DeltaV Simulate environment and support a train-the-trainer handoff so the custom

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Contract

Depends on Experience

Business Analyst with Clinical Trails _12+ Years Experience

Remote

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5d ago

Requirement details: Role: Business Analyst with Clinical Trails Location: Remote Duration: 12+ Months Job Description: 10+ Years of Experience The Business Analyst (BA) will serve as a key liaison between clients, product teams, clinical operations, and technical delivery teams. The BA will gather, analyze, and translate complex clinical trial requirements into functional specifications for eSource, DDC, and eCOA solutions. This role requires strong understanding of clinical trial processes, d

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Contract, Third Party

Depends on Experience

Werum PAS-X MES Lead / Solution Consultant

Remote

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4d ago

Werum PAS-X MES Lead / Solution Consultant Location: Remote Duration: 9-12 month JD Skills- Werum PAS-X v3.18 or above MES, IOT,L2 systems 8-12 years of overall experience in Pharmaceutical Manufacturing, MES and other Digital Manufacturing solutions.Minimum 6+ years of hands-on experience in Werum PAS-X MES implementations, MBR designing,rollout and support.Strong experience in Pharma and Life Sciences manufacturing environments.Experience in global rollouts, MES deployments, upgrades, and go

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Contract

Depends on Experience

Job opportunity - Digital Engineer - POMS MES/100% Remote

Remote

•

2d ago

Client: Clinical research technology Company. Title: Digital Engineer - POMS MES Location: Remote Overview Client is seeking an experienced POMS MES Techno-Functional SME with deep expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical manufacturing environment. The ideal candidate will serve as a trusted advisor and bridge between business stakeholders, manufacturing operations, quality organizations, validation teams, and technical delivery teams to support,

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Contract

Depends on Experience

Digital Engineer - POMS MES

Remote

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9d ago

Job Description: Role: Digital Engineer - POMS MES Location: Remote Duration: Long term Job Description Client is seeking an experienced POMS MES Techno-Functional SME with deep expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical manufacturing environment. The ideal candidate will serve as a trusted advisor and bridge between business stakeholders, manufacturing operations, quality organizations, validation teams, and technical delivery teams to support, enha

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Contract, Third Party

Depends on Experience

Digital Engineer - POMS MES

Remote

•

2d ago

Hi, Greetings from Iflowsoft Solution sinc Title: Digital Engineer - POMS MES Location: Remote Overview Client is seeking an experienced POMS MES Techno-Functional SME with deep expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical manufacturing environment. The ideal candidate will serve as a trusted advisor and bridge between business stakeholders, manufacturing operations, quality organizations, validation teams, and technical delivery teams to support, en

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Full-time

Depends on Experience

Sr Mngr, Full Stack Clinical Platform Engineer

Remote or Almont, Colorado

•

Today

Description: Remote Our client seeks a Full Stack Clinical Platform Engineer to design, implement, and operate production-grade Generative AI and Machine Learning solutions that support Global Development Digital Transformation. The role sits at the intersection of data engineering and applied AI. It partners with Clinical Operations, Data Management, Regulatory, and IT to build and maintain modern data platforms and AI-enabled pipelines that underpin the transformation program. The position r

Contract

Associate Director, Biostatistics & AI

Remote

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Today

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare dis

Full-time

USD 173,800.00 - 217,000.00 per year

Associate Director, RBQM Data Enablement and Analytics

Remote or Massachusetts

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Today

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Accountabilities: Configure Centralized Monitoring platform, including DQA, QTLs and KRIs, to identify and manage critical study risk

Full-time

USD 154,400.00 - 242,550.00 per year

Solutions Engineer, Life Sciences

Remote

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Today

Who we are At Domino, we build software that helps the largest, AI-driven organizations build and operate advanced data science and AI solutions at scale. Our platform integrates a streamlined model development environment, MLOps capabilities, and novel features for collaboration, reuse, and reproducibility - all of which make data science teams more productive, reduce time to value, and ensure compliance. Our customers - like Johnson & Johnson, GSK, Bristol Myers, UBS, FINRA and the US Navy -

Full-time

USD 160,000.00 - 230,000.00 per year

MES & Industrial Automation Engineer (Remote - United States)

Remote or Minnesota

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Today

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant mat

Full-time

USD 106,000.00 - 145,750.00 per year

Lead Data Manager/SAS programmer (Job 1425)

Remote

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Today

About Us DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. Our experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike by leveraging advanced tools - including digital transformation, artificial intelligence, data analytics, cloud enablement, modeling, and sim

Full-time

USD 130,000.00 - 175,000.00 per year

Manager, IT Assurance and Compliance-Quality Systems

Remote

•

Today

Job Description Position Summary The Manager, IT Assurance and Compliance - Quality Systems is responsible for leading and managing the IT Quality Compliance program, ensuring alignment with corporate and site quality and compliance initiatives. This role oversees the establishment, maintenance, and continuous improvement of global IT assurance and compliance processes, including computer software assurance (CSA), software quality management (SQM), and regulatory compliance (GxP, SOX, and other

Full-time

21 cfr part 11 jobs in Baltimore, MD, USA