21 CFR Part 11 Jobs

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Manhattan Techno Functional Consultant - WMS/TMS/ERP

Sriven Systems Inc.

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Chicago, Illinois, USA

Full-time

Title: This is a Hybrid in position in Waukegan, IL. We have a client looking for a Techno Functional WMS consultant (Manhattan Active) for a 12 month+ project. This role can be remote but must be on site up to 2 weeks a month in the Chicago area. Top Skills Details 9+ years of SAP WM (Warehouse Management)9+ years of SAP TM (Transportation Management) Description We are seeking a highly skilled Techno-Functional Contractor with deep expertise in Warehouse Management Systems (WMS) preferably Ma
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Posted 1 day ago

Director, Clinical Data Management

IO Associates

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Boston, Massachusetts, USA

Full-time

An innovative early-stage biotech company developing next-generation oncology therapies is seeking a Director of Clinical Data Management to build and lead its data function from the ground up. Reporting to the VP of Clinical Operations, this role offers a rare opportunity to shape data strategy, systems, and infrastructure in a fast-moving environment. Key Responsibilities: Build and scale the CDM function across internal staff and vendors Lead all data activities for early and late-phase onco
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Posted 11 hours ago | Updated 3 hours ago

Veeva Presales Consultant

NexInfo Solutions, Inc.

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Remote

Contract

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content
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Posted 24 days ago | Updated 7 hours ago

Clinical Systems Specialist

Tandym Tech

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Woburn, Massachusetts, USA

Contract

A biotech company in Massachusetts has a great Remote contract opportunity awaiting a new Clinical Systems Specialist. In this role, the Clinical Systems Specialist will be responsible for supporting the lifecycle management of clinical systems for Global Development Operations. To be considered for this opportunity, the qualified professional must be able to work on a W2 basis. Responsibilities: Work on planning, design, configuration, and deployment of new clinical systems and enhancements
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Posted 10 days ago | Updated 3 hours ago

Automation Controls Engineer (2ndShift)

Bytecubit Technologies

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Indianapolis, Indiana, USA

Contract

Job Title: Automation Controls Engineer (2nd Shift)Location: Indianapolis, INDuration: 6 monthsPay Rate: $45/hr-$55/hr (depending on experience) Job Description: This role will be responsible for supporting the design, installation, and validation for the sterile purification and recycling isolators into commercial production. Bachelor s degree in engineering, Computer Science, Automation, or related field with 7+ years of relevant engineering experience in the Pharmaceutical or Chemical indust
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Posted 30 days ago

Oracle OPM Consultant

Arcturus Consulting Services Inc.

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Albany, New York, USA

Contract, Third Party

Role: Oracle OPM Consultant Location: Albany, New York (onsite) Experience Level: 10+ years Project Type: Application Managed Services (AMS) Job Summary: The Oracle OPM Consultant will be responsible for the managing the support project including but not limited to implementation, configuration, and ongoing support of Oracle Process Manufacturing (OPM) modules within the pharmaceutical manufacturing environment. The role requires expertise in Oracle OPM and its integration with other Oracle modu
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Posted 22 days ago

MS Dynamics Platform Product Lead / Integration Tech Lead

ARMO Consultants

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Parsippany-Troy Hills, New Jersey, USA

Full-time

About the Role:We are seeking a senior-level Tech Lead with deep expertise in Microsoft Dynamics 365 and the Power Platform to lead the design, development, and integration of enterprise-grade solutions across our pharmaceutical business units. This role combines product ownership, technical leadership, and hands-on development, with a strong focus on automation, compliance, and scalability.Key Responsibilities:Lead architecture, development, and integration of Microsoft Dynamics 365 (CE, F&O) a
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Posted 14 days ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 55 days ago | Updated 11 hours ago

IT infrastructure CSV Consultant

Katalyst Healthcares and Lifesciences

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Cranbury, New Jersey, USA

Full-time

Responsibilities: We are seeking a Validation & IT Systems Specialist to join our dynamic team. This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications. IT Infrastructure guy who has worked in the Pharma industry, having 21 CFR part 11 exp. Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment. Manage system configurations, troubleshooting
Posted 60+ days ago | Updated 11 hours ago

CSV Engineer Role

Katalyst Healthcares and Lifesciences

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Massachusetts, USA

Full-time

Job Description: The CSV Engineer will be responsible for validating and verifying computerized systems that control or interface with laboratory equipment, ensuring data integrity and compliance. This includes writing, reviewing, and executing validation documents in alignment with regulatory expectations. Responsibilities: Validate GxP computerized systems/analytical instruments such as liquid handlers, Cellaca MX, and robotic arms. Lead development and execution of Data Integrity documentat
Posted 55 days ago | Updated 11 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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Johns Creek, Georgia, USA

Full-time

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g., GAMP5), FDA regulations (21 CFR Part 11, 210, 211, 820 as applicable), and validation of automated manufacturing/control systems. Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus). Responsibilities: Perform tasks under S
Posted 60+ days ago | Updated 11 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 11 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end
Posted 60+ days ago | Updated 11 hours ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

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San Francisco, California, USA

Full-time

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 60+ days ago | Updated 11 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: 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 vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 23 days ago | Updated 11 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 60+ days ago | Updated 11 hours ago

Aveva / OSIsoft PI Integration AWS Developer

U.S. Tech Solutions Inc.

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Remote

Contract

Location: 100% Remote Duration: 12 Months Job Description: Seeking a hand-on and experienced Senior Developer with 5+ years of experience in core AWS services. They will work with the team to design, build, and apply best practices. Key Responsibilities: The ideal candidate will have strong programming skills with extensive experience in AWS services.Design and implement back-end services using AWS lambda, Glue, Step Functions, API Gateway, S3, Aurora Postgres, Event Bridge and CloudWatch.Exper
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Posted 13 hours ago

Validation Engineer

Merck KgaA

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Miamisburg, Ohio, USA

Full-time

Work Location: Miamisburg, Ohio Shift: No Department: LS-SC-PEMM Engineering & Maintenance Recruiter: Renay Middleton Hiring Manager: John Shay This information is for internals only. Please do not share outside of the organization. Your Role: In this role you will develop and execute validation protocols to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This role is crucial for maintaining the quality and integrity of manufacturing processes and produ
Posted 10 days ago | Updated 11 hours ago

Onsite Contract: eDiscovery CyberSecurity Onsite Consultant ( Digital Forensics, Cybersecurity Investigations, EDRM )

Seine LLC

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Waukesha, Wisconsin, USA

Contract

Title: Onsite Contract: eDiscovery Cyber Security Onsite Consultant (Digital Forensics, Cybersecurity Investigations, EDRM ) Duration: 6-12 months 100% onsite in Waukesha, WI Industry: Medical Device/Healthcare Strong Microsoft Product expertise: OS365,Sharepoint, Exchange, Active Directory, Windows Endpoints Technical Tools: eDiscovery ( Relativity, Nuix, EnCase) Compliance: HIPAA, GDPR Regulatory: FDA, HIPAA, GDPR The eDiscovery (Cybersecurity) Specialist will be responsible for supporting l
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Posted 1 day ago | Updated 18 hours ago

IT Project Manager

Korn Ferry

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Bloomington, Indiana, USA

Contract

Title: IT Project Manager - Pharmaceutical Location: On-site, Bloomington, IN Client Industry: Pharmaceutical Manufacturing/Life Sciences Compensation: $50 - $65/hr. We have partnered with our client in their search for a high-visibility, on-site IT Project Manager role overseeing the full project life-cycle for multiple technology initiatives in a regulated pharmaceutical manufacturing environment. You will drive schedules, budgets, resources, vendors, and quality-using Smartsheet and standa
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Posted 10 days ago | Updated 3 hours ago