21 cfr part 11 jobs in philadephia, pa

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

Clinical Project Manager with RBQM, Veeva, CTMS, eTMF, EDC

Remote

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29d ago

Title: Clinical Project Manager with RBQM & Veeva Foster City, CA or Remote for people who can travel for meetings Experience Range: 10- max 22 years Writeup Skills PM with BA background and experience 6+ years of proven expertise in theclinical domain and operations, including hands-on experience with systems likeCTMS, eTMF, RBQM, and EDC. 8+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. 6+ years of

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Full-time

Depends on Experience

MES Project Manager

Remote

•

Yesterday

Title: Sr Project Manager Location: Remote Duration: 6+ Months C2H 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 applie

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Contract

Depends on Experience

Computer System validation Engineer

Wilmington, Delaware

•

Today

Hi, Title:Computer System validation Engineer Compute System Validation(CSV) with R&D Knowledge Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system Knowledge, Experience and Skills: { CORE CSV 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic r

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

Computer System Validation Engineer

Wilmington, Delaware

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Today

Roles & Responsibilities : 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes uthoring of URS/FS, protocols, final reports, validation plan/report High-level understanding of Veeva Vault suits Risk-based testing aligned to CSA fundamentals High-level understanding of Biostatistics, Clinical, Discovery, Med

Full-time

Senior Principal EA Research Technology

Philadelphia, Pennsylvania

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Today

Description Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines. Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our e

Full-time

Depends on Experience

Associate Director, Quality (Validation and Data Integrity)

Philadelphia, Pennsylvania

•

Today

Description: The Company: This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive,

Full-time

Senior Controls Engineer

Philadelphia, Pennsylvania

•

Today

Detailed description Wunderlich-Malec Engineering (WM) is a 100% employee-owned ESOP and one of the largest and most well-established engineering companies in the United States. When you join WM you become part of a company that is: 100% employee-owned with 40+ years of industry historyENR (Engineering News Record) Top 500 firmRated as a top System Integrator Giant We have a Senior Controls Engineer position available in Philadelphia, PA. This person will play a critical role in designing and i

Full-time

USD 110,000.00 - 160,000.00 per year

MES Project Manager

Remote

•

Today

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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Contract, Third Party

Depends on Experience

Lead LIMS Developer (SAPIO/LabVantage & Java)

Remote

•

Yesterday

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

•

Today

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

•

Today

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

•

Today

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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Yesterday

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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3d 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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2d 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

•

Today

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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7d 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

•

Today

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

21 cfr part 11 jobs in Philadelphia, PA, USA