21 cfr part 11 jobs in detroit, mi

One Maximo Global System Administrator :: Remote

Remote

•

3d ago

The IT One Maximo Global System Administrator supports and manages OneMaximo (MAS 8.x/9.x) environments across 11 global sites, ensuring compliance with 21 CFR Part 11, GMP practices, CIS policies, and global change controls. The role covers system validation, AWS/RHOS infrastructure management, integrations (SAP/MRO/MES), KPI dashboarding (Power BI), and global documentation management. Key ResponsibilitiesMaintain and support 5 global environments across AWS/RHOS platforms (DEV, STAGE, TRAIN,

Easy Apply

Contract

Depends on Experience

Validation Lead

Remote

•

23d ago

Job Title: Validation Lead Location: Fully remote Duration: Long term contract Educational Qualification* BE, Comp Science, BCA, BSE computer science Job Description of Role* (RNR) Proven leadership in testing/validation for medium to large system implementations, ensuring GxP compliance and quality delivery. Extensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomes. Proficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoi

Easy Apply

Full-time, Third Party

$0 - $0

Google Cloud Platform Auditor - IT SaaS

Remote

•

4d 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

Easy Apply

Contract

Depends on Experience

Senior Clinical Data Manager

Remote

•

5d 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

Easy Apply

Contract, Third Party

$50 - $90

R&D Business Systems Lead (BSA/PM) with Life Sciences -GxP Expereince

Remote

•

6d ago

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: R&D Business Systems Lead (BSA/PM) Location: Cambridge, MA (Remote) Duration: 12+ months Qualifications & Experience Required: 8+ years of combined experience in Life Sciences IT, including:Minimum 4 years in a GxP-regulated system administrator or support capacity.Minimum 4 years in project management, delivering cross-functional systems in R&D or Clinical domains.Str

Easy Apply

Contract

Depends on Experience

Backend .NET API Developer (with strong AWS)

Remote

•

11d ago

Title: Senior Backend .NET API Developer Client: Augusta Location: REMOTE Duration: 6 Months Work Hours: 40hrs/week Key Responsibilities API Development & Architecture AWS DynamoDB Expertise Cloud & Infrastructure Required Qualifications Technical Skills 10+ years of professional software development experience. Strong experience in .NET Core / ASP.NET Core, C#, and object-oriented programming. Proven expertise in AWS DynamoDB (data modeling, performance tuning, and operational best practices).

Easy Apply

Contract

$50 - $55

Backend .NET API Developer (Health Care) - Remote

Remote

•

12d ago

Title: Senior Backend .NET API Developer Client : Augusta Location: REMOTE Duration: 3 Months with Possible Extension Work Hours: 40hrs/week Key Responsibilities API Development & Architecture AWS DynamoDB Expertise Cloud & Infrastructure Required Qualifications Technical Skills 10+ years of professional software development experience. Strong experience in .NET Core / ASP.NET Core, C#, and object-oriented programming. Proven expertise in AWS DynamoDB (data modeling, performance tuning, and oper

Easy Apply

Third Party

$50 - $55

W2-Remote :: Senior QA Auditor / Computer System Validation (CSV) in Life Sciences Domain

Remote

•

Yesterday

Senior QA Auditor / Computer System Validation (CSV) in Life Sciences Domain 6-12 Months EST Zone (Remote) Position Overview: An accomplished Senior QA Auditor with a background in life sciences is required for a contract position that could extend from 6 months up to 12 months, with potential for permanent employment. This professional will play a vital role within a dynamic 18-person team, focusing on quality assurance and regulatory compliance across the US&C regions. The role entails perfor

Easy Apply

Full-time

Depends on Experience

Controls Engineer (DeltaV)

Remote

•

Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

Easy Apply

Full-time

USD 120,000.00 - 160,000.00 per year

Lead Engineer - MES Opcenter

Remote or New York

•

6d ago

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

Full-time

Maximo Consultant | 100% Remote | C2C Profiles Only

Remote

•

3d ago

Role: Maximo Global Admin Location: 100% Remote The IT OneMaximo Global System Administrator supports and manages OneMaximo (MAS 8.x/9.x) environments across 11 global sites, ensuring compliance with 21 CFR Part 11, GMP practices, CIS policies, and global change controls. The role covers system validation, AWS/RHOS infrastructure management, integrations (SAP/MRO/MES), KPI dashboarding (Power BI), and global documentation management. Key ResponsibilitiesMaintain and support 5 global environmen

Easy Apply

Contract

Depends on Experience

One Maximo Global Admin :: Remote :: C2C

Remote

•

3d ago

Role: One Maximo Global Admin Location: Remote(EST) The IT OneMaximo Global System Administrator supports and manages OneMaximo (MAS 8.x/9.x) environments across 11 global sites, ensuring compliance with 21 CFR Part 11, GMP practices, CIS policies, and global change controls. The role covers system validation, AWS/RHOS infrastructure management, integrations (SAP/MRO/MES), KPI dashboarding (Power BI), and global documentation management. Key ResponsibilitiesMaintain and support 5 global environ

Easy Apply

Third Party, Contract

Depends on Experience

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

Remote

•

25d ago

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

Easy Apply

Full-time

Depends on Experience

One Maximo Global Admin

Remote

•

6d ago

Trident Consulting, one of the fastest-growing IT staffing and services firms in the nation. We are currently seeking a "One Maximo Global Admin" for one of our industry leading clients. Please find additional details about the role below: Role: One Maximo Global Admin Location: Pittsburgh, PA/ Remote Duration: Contract Global Change Controls: New Aws/ RHOS GMP/ Qualified Platform (Non-Validated) DEV/ STAGE/ TRAINNew Aws/ RHOS GMP/ Qualified Platform (Validated) TEST/PROD/GOLDData Integrity Asse

Easy Apply

Contract, Third Party

Depends on Experience

Senior Commissioning, Qualification & Validation (CQV) Engineer

Remote or Athens, Georgia

•

Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

Sr Manager, IT Business Analysis - SAP BRH Architect

Remote or Foster City, California

•

Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 169,320.00 - 219,120.00 per year

OneMaximo Global Admin

Remote

•

9d ago

Role : OneMaximo Global Admin Location : Remote IT OneMaximo Staff Aug as Global System Admin requires in-depth understanding of the OneMaximo system and configurations, including proprietary tools from ABS Consulting. This position supports the system infrastructure (for 5 environments) 11 global sites, performance monitoring, with understanding of OMX policies and procedures to support potential Global TrackWise Deviations, CIS policies and procedures, new user requirements, updates Global con

Easy Apply

Contract, Third Party

Depends on Experience

Staff Software Quality Engineer

Remote or Santa Clara, California

•

Today

Full-time

USD 141,000.00 - 227,700.00 per year

Principal SAP Architect, Enterprise Asset Management (EAM)

Remote

•

Today

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pat

Full-time

USD 154,142.00 per year

Computer System Validation Analyst - R Studio & Clinical Systems

Remote or New Jersey

•

11d ago

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

Full-time

Filter Results

Job post features

Posted date

Work settings

Employment type

Distance

Employer type

Work authorization

21 cfr part 11 jobs in Detroit, MI, USA