21 CFR Part 11 jobs

Sr. IT Project Manager (Data Analytics & Business Intelligence)

Hybrid in St. Petersburg, Florida

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Today

Sr. IT Project Manager (Data Analytics & Business Intelligence)St. Petersburg, FL (Hybrid)Contract to Hire Job OverviewWe are seeking a Sr. IT Project Manager with strong expertise in Data Analytics & Business Intelligence to lead a global analytics program from a project management standpoint. This is a strategic initiative within the healthcare and medical devices industry, with high visibility and impact.This role supports a high-priority global program focused on modernizing enterprise data

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Contract

Depends on Experience

Senior Account Executive - Healthcare & Life Sciences

New York, New York

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6d ago

Urgent requirement- Senior Account Executive - Healthcare & Life Sciences - New York,NY (4day onsite)-United States Job Title:Senior Account Executive - Healthcare & Life SciencesJob Type: Full-TimeLocation: New York, NY -United States Job Description We're seeking a seasoned Senior Account Executive to drive sales growth and establish strong relationships with key decision-makers in this critical sector. Our cutting-edge compliance software solutions are designed to help healthcare organizati

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Full-time

$180,000 - $200,000

Computer System Validation Engineer

Hybrid in Raritan, New Jersey

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2d ago

Role - Computer System Validation Engineer Location - Raritan, NJ(Hybrid) Job Details: 5-10 years experience in Computer System Validation of GxP systems Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation 5+ years of experience in validating SAP application implementation, test script review, test execution review, test defect management. Has working experience in any one or

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Contract, Third Party

$55 - $60

GenAI Evaluation Engineer

Remote

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Today

Job Title: GenAI Evaluation Engineer Location: RemoteDuration: Long Term Required Qualifications:BS/MS in Computer Science, Statistics, Engineering, or a related field.2 5 years of experience in ML evaluation, QA engineering, or analytics, ideally in regulated domains.Proficiency in Python, pandas, and NumPy.Hands-on experience with evaluation libraries like NLTK, HuggingFace evaluate, and sacrebleu.Strong statistical rigor, with a deep understanding of metrics like Cohen s Kappa.Experience with

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Contract

Depends on Experience

Automation & Operational Technology Engineer

Walkersville, Maryland

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Today

Automation & Operational Technology (OT) Engineer Location: Walkersville, MD Duration: 6 Months+ Description: Designs automated equipment and machinery used to complete otherwise manual processes and tasks. Implements automated tests designed to evaluate integrity of automated systems. Defines areas where introducing automation could improve production and efficiency. Provides technical support in relation to automated systems when necessary. Writes documentation manuals that detail automated pr

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Contract, Third Party

Depends on Experience

Business Analyst Life Sciences (Salesforce Service Cloud)

Irvine, California

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7d ago

Job Title: Salesforce BA Service Cloud Experience : 9+ Years Location: Irvine, California (Onsite 5 days) Mode of Work: Irvine, California - Onsite Start Date Immediate Industry: Pharma Project Duration: Long term Job Description: Business Analyst Life Sciences (Salesforce Service Cloud) Position Overview We are seeking a Business Analyst (BA) with strong expertise in Salesforce Service Cloud and deep knowledge of Life Sciences business processes. The successful candidate will serve as a liaiso

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Contract

$40 - $50

Clinical Data Engineer/Analyst

Remote

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7d ago

Qualifications: Bachelor s or Master s degree in Computer Science, Data Engineering, Life Sciences, or a related field.3+ years of experience in data engineering, preferably within clinical research, pharma, or healthcare domains.Strong experience with ETL/ELT tools, data integration, and data ingestion pipelines.Proficient in SQL, Python, and/or Scala for data engineering tasks.Experience with cloud-based platforms such as AWS, Azure, or Google Cloud Platform, and tools like Databricks, Snowfla

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Third Party, Contract

Depends on Experience

Validation Engineer

Raritan, New Jersey

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Today

Job Description: We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation skills. This role is critical in ensuring compliance, validation, and accurate documentation of enterprise applications, particularly in regulated environments (GxP/21 CFR Part 11). Responsibilities: Perform Computer System Validation (CSV) activities for SAP and OpenText systems. Develop and execute validation protocols (IQ, OQ, PQ

Full-time

Computer System Validation Engineer

New Jersey

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 3-7 years of experience in CSV within pharmaceutical, biotech, or medical device industries. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines. Experience with ERP, LIMS, MES, or other GxP systems. Extensive Experience in HPALM with Manual testing. Deep knowledge in Defect Management Life cycle. Proficient in writing validation protocols, reports, and SOPs

Full-time

CSV Engineer

Atlanta, Georgia

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2d ago

Expertise in 21 CFR Part 11, Annex 11, and GAMP 5 compliance Experience updating validation procedures (change control, training, audits) Ability to write and review technical validation documents: Validation Plan URS, FRS Risk Assessment, Traceability Matrix IQ/OQ/PQ protocols and reports Responsibilities Support system validation project activities: Writing protocols Reviewing/approving test scripts Drafting validation reports Review and approve Change Control requests and assess impact on val

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Contract

$30 - $50

CSV Consultant

Dallas, Texas

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5d ago

Serve as the CSV (Computer System Validation) Lead for SAP S/4HANA Supply Chain & Warehouse Management modules Partner with SAP configurators to document workflows, processes, and validation deliverables Drive a risk-based validation approach in compliance with GxP and GMP standards Focus on Performance Qualification (PQ) as a core element of the validation strategy Provide oversight of digital computerized systems supporting the supply chain Lead and support audits, change control processes, an

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Full-time

Depends on Experience

Validation Engineer

Indianapolis, Indiana

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Today

Responsibilities: Provide application/system validation expertise for standalone, enterprise, and integrated systems in a regulated (GxP) environment. Lead OT system qualification and validation, including Client/DCS integrated with manufacturing equipment. Support qualification activities in Radio Ligand Therapy (RLT) or critical dosage forms (preferred). Author and review Validation Plans, Test Scripts/Protocols, and Validation Summary Reports. Ensure alignment with SDLC deliverables and

Full-time

Senior Clinical Data Manager

Remote

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22d ago

100% Remote Job Description Senior Clinical Data Manager Role Overview We are seeking an experienced Clinical Data Manager (CDM) to support multiple outsourced clinical studies. The ideal candidate will have strong hands-on expertise in EDC systems, data review activities, vendor data reconciliation, and CRO oversight. Responsibilities Manage 4 concurrent clinical studies outsourced to CROs, ensuring data integrity and compliance. Oversee day-to-day data review activities in the EDC, including

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Contract, Third Party

$50 - $90

Google Cloud Platform Auditor - IT SaaS

Remote

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22d ago

Education: Bachelor s degree in Life Sciences, Pharmacy, Chemistry, or a related field.Experience: Minimum 10+ years in Healthcare/Pharma QA, including 7+ years in Google Cloud Platform audit (preferably in SaaS platforms).Vendor Audits: Ability to assess third-party SaaS providers for compliance with contractual and regulatory obligations.Regulatory Knowledge: Strong expertise in ICH Google Cloud Platform E6, FDA, EMA, HIPAA, 21 CFR Part 11, and global standards. Experience working with clinica

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Contract

Depends on Experience

CSV Engineer

San Francisco, California

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Today

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. Roles & Responsibilities: 10Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnol

Full-time

Software Validation Engineer

Plymouth, Minnesota

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Information Technology, Electronics Engineering, or a related field. Minimum 5-8 years of experience in software validation, preferably within the medical device, pharmaceutical, or regulated healthcare industries. Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles. Experience in handling SW development and verification tools. Good

Full-time

CSV Engineer / CSA Engineer / Computer System Validation

Santa Clara, California

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Yesterday

Hello Associate, Hope you are doing great, Below positions Open, Please share resumes Role: CSV Engineer / CSA Engineer / Computer System Validation Location: Santa Clara CA Duration: Long Term 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 Year

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Contract, Third Party

Depends on Experience

SAP MM/PTP Consultant

Texas

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6d ago

Lead the design and implementation of SAP PTP processes tailored to pharmaceutical supply chain and distribution operations.Configure SAP MM, including purchasing, inventory management, and invoice verification.Ensure compliance with GP, FDA 21 CFR Part 11, and other regulatory requirements.Collaborate with stakeholders to gather business requirements and translate them into SAP solutions.Integrate SAP PTP with SAP WM/EWM, SAP QM, and SAP FI for seamless end-to-end process execution.Support proc

Third Party

$65 - $70

SAP MM/PTP Consultant

Texas

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6d ago

Third Party

$65 - $70

PCS 7 Validation Engineer

Hybrid in Redmond, Washington

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20d ago

Job Title: PCS 7 Validation Engineer Job Location: Redmond, WA Hybrid Eligibility/Clearance: Must be authorized to work in the US Job Description: We are looking for a highly skilled and detail-oriented PCS 7 Validation Engineer to join our Automation/Validation team. In this critical role, you will be responsible for developing, authoring, and maintaining the foundational documentation required to validate Siemens PCS 7 control systems in a regulated GxP environment. Your expertise will be es

Full-time

$75 - $85

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21 CFR Part 11 jobs