21 CFR Part 11 jobs in Massachusetts

OT Security Architect----Bedford, MA -- candidates can work for any Client office--Hybrid

Hybrid in Bedford, Massachusetts

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19d ago

OT Security Architect Bedford, MA -- candidates can work for any Client office Skills: OT--Hands on strong exp risk management pharmaceutical cyber Rockwell PL Ignition SCADA compliance with EU Cyber Resilience Act (CRA) IEC 62443/ISA99 ISA 95 GMP FDA 21 CFR Part 11 Certification--added advantage at least try for few IEC 62443 Cybersecurity Expert GICSP / CISSP Rockwell Automation Sirisha N Sr IT Analyst Humac Inc.

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Contract, Third Party

Depends on Experience

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

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28d ago

Must Have Technical/Functional Skills :8+ years in IT and Quality Assurance.5+ years supporting Pharma/Life Sciences customers.Experience leading global testing services delivery across US, UK, and India.Strong customer-facing and stakeholder management skills.Test Strategy & GovernanceFunctional, Integration, UAT, and Regression TestingData Testing & ValidationRoles & Responsibilities: Own end-to-end Testing & Validation service delivery across multiple Pharma projects Lead onsite/offshore QA t

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Full-time

110,000 - 130,000

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

Remote

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11d 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

Staff Compliance Manager / GxP

Cambridge, Massachusetts

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Today

A commercial SaaS company that works in the biotech and medtech space is looking for a Staff level Compliance Manager to come in and ensure their software products are in FDA, HIPPA, ISO, SOC, etc compliance. You'll ensure that their validation processes are aligned with their software products, handled product release management oversight, and be responsible for the organization's compliance frameworks. Ideal candidates have experience with 21 CFR Part 11 and EU Annexx 11, as well as have devel

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Full-time

$170000 - $190000

CSV Engineer

Woburn, Massachusetts

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Today

Job Summary: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer S

Full-time

SAP BRH Functional / Support Lead

Remote

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Today

Job Summary: Seeking a Senior SAP Batch Release Hub (BRH) Functional/Support Lead with strong SAP BRH and S/4HANA QM expertise to support implementation, production sustainment, hyper care, and go-live activities in a regulated Life Sciences environment. Key Responsibilities Lead SAP BRH implementation, design, and production support. Handle P1/P2 incidents, RCA, defect resolution, integration troubleshooting, and hypercare. Support S/4HANA QM, including batch management, inspection lots, usage

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Contract

Depends on Experience

Mendix Platform Architect

Remote

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2d ago

Mendix Platform Developer/Architect|| Location Jacksonville, FL Remote || Employment type - contract Job Description: 10 years of software development experience. 5 years of Mendix development experience Experience serving as a solution architect or technical lead. Experience delivering enterprise-scale applications. Technical Skills Mendix Platform Architecture Mendix Studio Pro Microflows and Nanoflows Domain Modeling XPath and OQL Java Actions REST and SOAP APIS SQL Databases Azure

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Third Party, Contract

$65 - $70

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

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Today

Job Summary: leading organization is seeking an experienced Pharma IT Testing & Validation Delivery Lead to manage global testing and validation services across multiple Life Sciences programs. Roles & Responsibilities: Own end-to-end testing and validation delivery across multiple pharmaceutical IT projects. Lead onsite and offshore QA teams across the United States, United Kingdom, and India. Define testing strategy, governance, KPIs, delivery standards, and quality metrics. Oversee functional

Full-time

Junior Validation Engineer with CSV / CQV

Cambridge, Massachusetts

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17d ago

Arthur Lawrence is looking for a Junior Validation Engineer with CSV / CQV one our clients in Cambridge MA. Please find the job description below and send us your updated resume if interested: Must-Have Skills: Experience performing validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment in compliance with GMP and 21 CFR Part 11 requirements. Hands-on experience supporting Master Validation Plans (MVPs), SOPs, validation protocols, and Process Per

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Contract, Third Party

$30 - $39

Business Application & Systems Administrator

Boston, Massachusetts

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Today

Job Description The Business Applications & Systems Administrator is responsible for managing, implementing, and optimizing business applications. The role will develop & coordinate testing with impacted departments, including specifically coordinating with IT and Quality for validation & compliance. Manages business application projects, ensuring effective communication across teams/functions as well as informing management of progress and key issues. Key Responsibilities Application Managem

Full-time

USD 116,800.00 - 219,000.00 per year

Senior PLM Windchill Solution Architect

Remote

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4d ago

Position OverviewWe are looking for aSenior PLM Windchill Solution Architectto lead a strategic, customer-facing PLM engagement for a leadingMedical Device / Life Sciences organization.The ideal candidate will be a senior techno-functional architect with strongPTC Windchill PLMexpertise and experience owning end-to-end architecture, technical governance, integrations, migration, validation, AMS, and customer stakeholder management.Key ResponsibilitiesLead end-to-endPTC Windchill PLM solution arc

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Contract

80 - 90

Senior Technical Business Analyst

Remote

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5d ago

DescriptionJob Title: Senior Healthcare Business Analyst Type: Part Time Experience Level: Senior Seeking a highly skilled and experienced Senior Business Analyst responsible for bridging the gap between business objectives and technology solutions, ensuring that our projects align with organizational goals and deliver maximum value. You will utilize your expertise in business analysis and data-driven decision-making to identify opportunities for improvement and drive successful project outcomes

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Part-time

Depends on Experience

Sr SampleManager Implementation Engineer

Remote or Indiana

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior SampleManager LIMS Implementation Engineer How will you make an impact? As a Senior SampleManager LIMS Implementation Engineer, you will be a technical expert responsible for the configuration, implementation, integration, and deployment of Thermo Scientific SampleManager LIMS solutions. This role is highly hands-on and focused on translating defined laboratory processes and solution designs into robus

Full-time

USD 93,800.00 - 140,675.00 per year

Project Manager- Life science industry

Remote

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13d ago

Job Title: Project ManagerLife science industryLocation: Foster City, CA (Fully remote)Duration: FTEEducational Qualification*Any Bachelor''s DegreeExperience Range10 YearsTagline/Tech Stack Snapshot -PM with BA background and experienceRole Summary - (To be filled by Practice /DO)We are seeking a PM and Business Analyst with requirements gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating bu

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Full-time, Third Party

0 - 0

Associate Director, Data Analytics and Technical Solutions

Waltham, Massachusetts

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Today

Job Description Reporting to the Director, Data Analytics and Technical Solutions, this position is responsible for designing, maintaining and governing the Technical Solutions' clinical data ecosystem. This position will bridge the gap between complex clinical data sources and actionable business intelligence metrics utilized by Clinical Operations, Data Management and Clinical Programming departments within the Clinical Development Operations organization. Responsibilities Support the Clini

Full-time

USD 167,000.00 - 190,000.00 per year

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

Senior Staff Software Advance Quality Engineer

Remote or Detroit, Michigan

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Today

Work Flexibility: Remote or Hybrid or Onsite It's Time to Join Stryker! Why Join Us In this role, you will help shape software quality practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate quality, compliance, security, and risk management into development while establishing scalable processes that support innovation and efficient delivery. Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our

Full-time

USD 102,600.00 - 171,000.00 per year

Director, Data Management

Waltham, Massachusetts

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Today

Job Description This role provides strategic and operational leadership for Clinical Data Management activities supporting the company's clinical development portfolio. This position is responsible for ensuring the delivery of high-quality, reliable, and inspection-ready clinical data through effective planning, oversight, and execution of data management activities across both internally managed and outsourced clinical studies. The Director partners closely with cross-functional stakeholders,

Full-time

USD 205,000.00 - 230,000.00 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

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Waltham, Massachusetts

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Today

Job Description This position provides leadership and accountability for Digital Quality across the organization's Quality, Regulatory, and R&D systems landscape, with responsibility for supporting computer system validation activities in alignment with applicable regulatory expectations, internal procedures, and data integrity requirements. The role is focused on ensuring GxP computerized systems are implemented, maintained, and governed in a compliant, risk-based, and inspection-ready manner

Full-time

USD 110,000.00 - 126,000.00 per year

21 CFR Part 11 jobs in Massachusetts, USA