21 CFR Part 11 Jobs

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Oracle OPM Consultant at Albany, New York

SAR TECH LLC

•

Albany, New York, USA

Contract

Hi PFA below requirement and let me know your interested Job title:Oracle OPM Consultant Location:Albany, New York Duration: Contract JD - Job Description-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 m
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Posted 5 hours ago

Senior Full Stack Engineer (.NET 8 / Angular / Azure)-- Minneapolis, MN- Hybrid (3 days in Office + 2 days from WFH)-Medical Device exp. is must

cyberThink, Inc.

•

Minneapolis, Minnesota, USA

Third Party, Contract

About the Role: We are looking for a Senior Full Stack Engineer with proven experience in modern web development using Angular (v14+), .NET 8, and Cosmos DB with Azure cloud ecosystems. You will be working on a connected medical device platform that collects therapy data and transmits it to an Azure-based cloud portal. This platform plays a vital role in improving patient care and helping clinicians and administrative teams manage healthcare delivery more effectively. This role is ideal for some
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Posted 16 days ago | Updated 16 days ago

Data Integrity QA Validation Engineer

Katalyst Healthcares and Lifesciences

•

Rensselaer, New York, USA

Full-time

Responsibilities: Participate on teams of internal resources in delivery of CSV projects. Author functional requirements specifications that are complete, accurate, and testable. Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessments. Author Validation Plans and Validation Reports. Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices. Experience in validation at least two of these computer system categories: automation contro
Posted 49 days ago | Updated 6 hours ago

Senior MES Engineer

PARAKEET WORLD SOLUTIONS LLC

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Raleigh, North Carolina, USA

Full-time

Position: Senior MES Engineer Location: Raleigh, NC Job Type: On site Education level: Bachelor s degree JOB DESCRIPTION:Design, develop, and implement MES solutions, acting as the project lead or team lead.Interact with clients to gather requirements and deliver high-quality MES systems.Oversee all project phases from concept to commissioning, ensuring alignment with Life Sciences regulations (GMP, 21 CFR Part 11, etc.).Lead project teams, manage budgets, and ensure timely delivery.Integrate
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Posted 5 days ago

LIMS Business Analyst

Arnex Solutions LLC

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Foster City, California, USA

Full-time

Required Skills & Qualifications: Bachelor's degree in Computer Science, Life Sciences, Biotechnology, or a related field. Overall Experience: 10+ Years Strong understanding of LabVantage/Labware/Similar configuration, customization, and integration capabilities. Proficient in database management (e.g., SQL) and scripting for LIMS workflows. Familiarity with laboratory workflows and operations in a regulated environment. Experience with data migration, system validation, and regulatory complianc
Posted 6 days ago | Updated 8 hours ago

Veeva Presales

InfoTech Spectrum Inc

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Remote

Contract

Title: Veeva Presales Location: Remote Job Description: 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 Creation & RFP Management Develop tailored responses to RFPs, RFIs, and capability assessments with detailed solution write-ups, compliance language, a
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Posted 1 day 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 2 days ago | Updated 2 hours 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 10 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 8 days ago

IBM Maximo EAM Techno-Functional SME

Skywaves MP LLC

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Pittsburgh, Pennsylvania, USA

Full-time

This is a C2C opportunity We are seeking an experienced IBM Maximo EAM Techno-Functional SME with deep expertise in the Life Sciences industry. This role will support Thermo Fisher Scientific s enterprise asset management needs and requires an individual who can contribute immediately without training or onboarding. Please note: Experience in Maximo for non-life science domains (e.g., automotive, oil & gas, utilities, transportation) is not relevant to this position. Key Responsibilities:Provide
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Posted 1 day ago

LIMS Architect

Macrosoft

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Bridgewater, New Jersey, USA

Contract, Third Party

As the LabVantage LIMS Architect, you will collaborate with stakeholders, including laboratory personnel, IT teams, and vendors, to design customized solutions that align with business objectives. Key Responsibilities: Solution Architecture and Design:Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models
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Posted 4 days ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

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 33 days ago | Updated 6 hours ago

Veeva Clinical Architect

Arnex Solutions LLC

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US

Third Party, Contract

Responsibilities: Solution Architecture Design: Lead the design and architecture of Veeva Vault solutions, ensuring alignment with business requirements and industry best practices. Develop and document high-level and detailed solution designs, including data models, workflows, integration patterns, and security frameworks. Implementation Oversight: Oversee the implementation of Veeva Vault applications, ensuring adherence to architectural standards and project timelines. Provide technical leade
Posted 6 days ago | Updated 8 hours ago

MES Architect

Macrosoft

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Bridgewater, New Jersey, USA

Third Party, Contract

We are seeking an experienced MES (Manufacturing Execution System) Architect with expertise in Tulip to design, implement, and manage our MES solutions within a biotech environment. This role will be responsible for leading the architecture and deployment of Tulip s platform across manufacturing operations, ensuring seamless integration with existing systems while meeting the specific regulatory and operational needs of a biotech company. The MES Architect will work closely with cross-functional
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Posted 4 days ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

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 40 days ago | Updated 6 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 49 days ago | Updated 6 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 33 days ago | Updated 6 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 1 day ago | Updated 6 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 49 days ago | Updated 6 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 49 days ago | Updated 6 hours ago