21 CFR Part 11 Jobs

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CSV Automation Engineer(Onsite) Location: North Kansas City, KS (Onsite)

Stellent IT LLC

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Kansas City, Kansas, USA

Third Party, Contract

Title - CSV Automation Engineer (Onsite) Location: North Kansas City, KS (Onsite) Duration: 3-6 Months (most likely 6) Industry: Pharmaceutical Job Description: We are currently seeking a highly experienced Computer System Validation (CSV) Automation Engineer to join an active pharmaceutical project in North Kansas City, KS. The engineer will play a key role in ensuring validated automation systems meet both regulatory and technical standards in a dynamic and fast-paced environment. The ideal
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Posted 7 days ago | Updated 10 hours 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 12 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 53 days ago | Updated 11 hours ago

MES Automation Support Engineer

Stellent IT LLC

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Raleigh, North Carolina, USA

Contract, Third Party

Job Title:- MES Automation Support Engineer Job Location:- Holy Springs NC (Onsite) Long Term Contract Position Overview: We are seeking a MES Automation Support Engineer to support the development and deployment of a DeltaV MES (Syncade) platform, enabling fully digital manufacturing with integrated ERP, MES, and DCS systems at a cutting-edge CDMO site. This role will involve collaborating closely with cross-functional teams to drive paperless operations and enforce validated workflows. Ke
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Posted 8 days ago | Updated 10 hours ago

Veeva Promo Mats Technical Architect-W2

Narvee Tech Inc

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Remote

Contract

Job Title: Veeva Promo Mats Technical Architect Duration: 12 Months (Possible Extension) Location: Remote/Hybrid Client Note: Minimum 2-3 end-to-end implementation required on Promo Mats.We are looking who have extensive experience in PROMOMATS. Only ask those who are hands-on with the projects who can describe the details of the project. Need Promo Mats expertiseJob Description Join IBM's Veeva Practice team as an Architect & Engineer for Veeva Commercial Cloud, where you will be a key leader i
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Posted 7 days ago

MES Support Lead

Cognizant

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Chicago, Illinois, USA

Full-time

Job Summary Application skill Business Analysis / Requirements gathering for MES Electronic Batch record implementation for a pharma client. Experience on Werum PAS-X System Administration, GMBRs, PVL, PMBR?s, Equipment Management, Material Flow, Weigh & Dispense, EBR, MBR & Master Data Designing and developing State Diagrams in MES Determining updates for Master Data, State Diagrams, Experience on SAP-MES interface, L2 integrations, report development Hands on Experience in Werum PAS-X Specif
Posted 42 days ago | Updated 23 hours ago

Veeva PromoMats Technical Architect - W2

Narvee Tech Inc

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Remote

Contract

Job Title: Veeva PromoMats Technical Architect Duration: 12 Months (Possible Extension) Location: Remote/Hybrid Client Note: Minimum 2-3 end-to-end implementation required on PromoMats.We are looking who have extensive experience in PROMOMATS. Only ask those who are hands-on with the projects who can describe the details of the project. Need PromoMats expertise Job Description Join IBM's Veeva Practice team as an Architect & Engineer for Veeva Commercial Cloud, where you will be a key leader in
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Posted 8 days ago | Updated 1 day 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

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 53 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 21 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

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/ 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

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 8 days ago | Updated 11 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 8 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Jersey City, New Jersey, USA

Full-time

Responsibilities: Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix. Possesses strong communication skills to interact with business stakeholders (Technology Leader, Project Manager, Business Owner). Ability to work with project team to facilitate intera
Posted 60+ days ago | Updated 11 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Summit, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems. Develops
Posted 11 days ago | Updated 11 hours ago

Full Stack Developer

Stefanini

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Minneapolis, Minnesota, USA

Contract

Stefanini Group is looking for Sr Full Stack Developer for a globally recognized company! For interested applicants, click the apply button or you may reach out to Alfher Hidalgo at / for faster processing. Thank you! 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 transm
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Posted 42 days ago | Updated 6 hours ago

Director Contract Research Organization (CRO) SME (Customer Success)

Saama Technologies, LLC

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Remote

Full-time

Director Contract Research Organization (CRO) SME (Customer Success)Location: RemoteDepartment: Customer Success Role OverviewWe are seeking a Director level Contract Research Organization (SME) with deep expertise in Clinical Data Management (CDM) and a modern understanding of clinical data workflows and analytics. This individual will play a critical dual role in ensuring delivery excellence across customer engagements and supporting strategic sales and pre-sales efforts. This is a highly visi
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Posted 4 days ago