21 cfr jobs | Dice.com

Project Manager/ Business Analyst (Clinical Operations)

Hybrid in Foster City, California

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Yesterday

Job Title: Project Manager/ Business Analyst (Clinical Operations) Location: Foster City, CA (Hybrid)Employment Type: Full-Time (FTE) Job SummarySeeking a Senior Project Manager / Business Analyst with strong Clinical Operations expertise and hands-on experience in Risk-Based Monitoring (RBM/RBQM). Responsible for requirements gathering, project delivery, stakeholder management, and implementation of clinical systems and monitoring processes. Key ResponsibilitiesLead requirements gathering for R

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Full-time

$160,000 - $160,000

Medical Device Engineer

Hybrid in Warsaw, Indiana

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Today

Job DescriptionWe are seeking a qualified Medical Device Engineer with experience in regulated medical device product development, engineering studies, and medical device standards. The ideal candidate will have strong technical writing and communication skills, knowledge of quality and regulatory requirements, and experience applying statistical methods to engineering studies. Required QualificationsBachelor's degree in Engineering with at least 3 years of relevant experience, or equivalent exp

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Full-time

$35 - $38

Clinical IT Business Analyst (VISA INDEPENDENT CANDIDATES ONLY)

Raleigh, North Carolina

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Today

Regulated environments such as CRO organizations experience is Huge plus Job Purpose: The Senior Business Analyst (SBA) partners closely with business and technical stakeholders to uncover the true needs of the organization and translate them into clear, actionable, and testable requirements. This role ensures solutions are designed with the end user in mind while meeting enterprise, quality, and regulatory expectations. Key Accountabilities: Elicit and define business requirements Identify true

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Contract, Third Party

Depends on Experience

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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9d ago

Job Title: GxP Project Manager Location: Bay Area, CA Duration: 6+ months with possible of extension Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.8+ years of Project Management experience within the Pharmaceutical or Biotechnology industry.5+ years managing GxP-regulated projects.Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11.Experience managing Computer System Validation (CSV)

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Contract, Third Party

$80 - $90

Validation Analyst

Hybrid in San Francisco, California

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Today

Role Overview Seeking an experienced Validation Analyst to support Roche's GIP program, focusing on validation of medical imaging applications, AI/ML workflows, and the Algorithm Workbench platform. The role will ensure system quality, regulatory compliance, data integrity, and end-to-end validation readiness. Key Responsibilities Develop and execute Computer System Validation (CSV) deliverables, including validation plans, risk assessments, IQ/OQ/PQ protocols, and validation summary reports.

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Full-time

60 - 70

Validation Analyst

Hybrid in San Francisco, California

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Today

Job Title: Validation AnalystProject: Medical Imaging & Algorithm Workbench Location: San Francisco, CA Work Model: Hybrid 4 Days Onsite Role OverviewWe are seeking an experienced Validation Analyst to support Roches GIP program, focusing on the validation of medical imaging applications, AI/ML workflows, and the Algorithm Workbench platform. The ideal candidate will ensure system quality, regulatory compliance, data integrity, and end-to-end validation readiness while supporting software rele

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Contract, Third Party

70 - 80

Loftware Spectrum Technical Lead

Remote

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3d ago

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

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Contract, Third Party

Depends on Experience

Business Systems Support Analyst

Laguna Beach, California

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8d ago

HonorVet Technologiesis a Service Disable Veteran-Owned IT staffing firm, ISO 9001, and ISO 27001 certified, working with federal agencies, state governments, and Fortune 500 enterprise clients across the US. What makes us different isn't a tagline; it's the way we work. We don't forward resumes and hope for the best. We take the time to understand where a professional like you are headed and only reach out when we genuinely believe there's a fit worth exploring. I came across your profile, and

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Contract

$26 - $33.85

Quality engineer

Reedsville, Pennsylvania

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23d ago

Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments. Key Resp

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Contract, Third Party

55 - 60

COMPONENT ENGINEER 3

Sunnyvale, California

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Today

Description: Position Overview The Supplier Engineer is responsible for ensuring suppliers reliably support plant production by meeting Intuitive requirements for quality, delivery, capacity, cost, and service. This role is highly execution-focused and serves as the primary technical interface between the plant and suppliers to resolve line-impacting issues, improve supplier manufacturing processes, and maintain stable production operations across multiple product families. The Supplier

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Contract, Third Party

$60 - $75

LIMS Master Data Specialist

Hybrid in Houston, Texas

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Today

Job Title: Master Data Specialist Location:- Houston, Texas, 77047 Duration:- 8 Months+ Role Summary The Local QC Lab Subject Matter Expert (SME) - Data Load is responsible for the accurate setup and loading of master data into the global Laboratory Information Management System (gLIMS) in accordance with global guidelines and data principles. This role plays a crucial part in ensuring data integrity and establishing local support structures for ongoing data management. Key Responsibilities Ma

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Third Party, Contract

Depends on Experience

Computer Systems Validation Engineer

Boston, Massachusetts

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Today

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

Component Engineer 4

Sunnyvale, California

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Today

Description: WOW: Minimum 3 Days onsite Job Title: Contingent Supplier Engineer MP Systems Department: Supplier Engineering Reports to: Sr Manager, Supplier Engineering Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority. Primary Function of Position: The mission of Supplie

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Third Party, Contract

$93 - $93

Technical Program Manager

Bell Gardens, California

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28d ago

Payrate: $90.00 - $100.00/hr. Responsibilities:Release Program Leadership:Manage deliverables to completion for Companys FDA approved Hearing Correction feature - software as medical device (SaMD) in accordance with Quality Management System (QMS) software release process end-to-end: define release scope, schedule, and milestones.Maintain a single source of truth for release status, dependencies, risks, and open items across all functions.Cross-Functional Coordination:Coordinate release activit

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Contract, Third Party

$90 - $100

CQV Engineer

Atlanta, Georgia

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13d ago

Summary: Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment. Roles & Responsibilities: Perform CQV activities for standalone equipment. uthor and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and validat

Full-time

CQV Engineer

Portland, Maine

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13d ago

Summary: Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment. Roles & Responsibilities: Perform CQV activities for standalone equipment. Author and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and val

Full-time

Quality engineer / Lead/ Manager - Medical Devices Manufacturing Experience

Reedsville, Pennsylvania

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22d ago

Role: Quality engineer / Lead/ Manager Medical Devices Manufacturing Experience Positions: 5 Openings Location: Reedsville, PA (Day 1 Onsite) Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield

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Contract, Third Party

Depends on Experience

CSV Validation Engineer

Plymouth, Minnesota

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13d ago

Summary: We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN. Roles & Responsibilities: Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports. Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports. Perform risk assessments, impact assessments, traceability, and change control activities. Support validation of GxP-regulated compu

Full-time

CSV Validation Engineer

Jacksonville, Florida

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13d ago

Full-time

SAP Validation

Remote

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23d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience