Gxp jobs in montpelier, vt

Technical Project Manager - SaMD / GxP Validation

Remote

•

Today

Technical Project Manager - SaMD / GxP Validation. We need an independent, Quality-first project manager to drive an imaging algorithm Software as a Medical Device (SaMD) program in R&D IT toward a trial launch targeted for Q3. You will run the plan, clear blockers and own the validation documentation, all within a regulated Quality Management System (QMS). This is a technology role, not clinical operations, and we want someone who can start delivering in week one. Engagement 12-month contract

Contract

$60.00 - $80.00

GxP Systems and Support Administrator

Remote

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Senior CQV Engineer

Montpelier, Vermont

•

14d ago

Job Description: We are seeking an experienced Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical, biotechnology, or life sciences manufacturing facilities. The role will support equipment, utilities, facilities, and manufacturing systems while ensuring compliance with GMP, FDA, GxP, and applicable industry standards. Responsibilities: Lead Commissioning, Qualification & Validation (CQV) activities for manufacturing equipment

Full-time

SAP Validation

Remote

•

24d 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

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

•

7d ago

Business Systems Analyst LMS Transformation & SAP SuccessFactors Learning Migration Sumtotal LMS experience is required. 12 month remote contract. $40 an hour w2. No C2C or 1099 at this time. EST or CST candidates preferredPosition SummaryMilestone is seeking an experienced Business Systems Analyst (BSA ) to support the enterprise Learning Management System (LMS) transformation initiative, including the migration from SumTotal LMS to SAP SuccessFactors Learning. The BSA will serve as the li

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

•

7d ago

Business Systems Analyst LMS Transformation & SAP SuccessFactors Learning Migration12 month remote project - Candidates should sit in CST or EST time zone. $40 an hour w2. No Corp to Corp or 1099 support at this time. Position SummaryMilestone is seeking an experienced Business Systems Analyst (BSA ) to support the enterprise Learning Management System (LMS) transformation initiative, including the migration from SumTotal LMS to SAP SuccessFactors Learning. The BSA will serve as the liaison

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

•

7d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

•

7d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

•

7d ago

Easy Apply

Contract

Depends on Experience

Sr. IT/OT Infrastructure Engineer - Manufacturing Digitalization at Cincinnati, OH (Remote)

Remote

•

9d ago

Position: Senior IT/OT Infrastructure Engineer - Manufacturing Digitalization Location: Cincinnati, OH (Remote) Duration: 3+ Months Job Description: We are seeking an experienced Senior IT/OT Infrastructure Engineer Manufacturing Digitalization to support manufacturing equipment digitalization, network connectivity, Data Integrity (DI) upgrades, MERA network onboarding, and VxRail infrastructure within a regulated manufacturing environment. The role will provide hands-on IT/OT infras

Easy Apply

Contract, Third Party

Depends on Experience

CSA/CSV Validation Consultant

Remote or Arlington, Virginia

•

Yesterday

Role - CSA/CSV Validation Consultant Remote Skills & Experience Required: empower or similar HPLC software Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain Familiarity with QMS processes including deviation management, CAPA, and change control. Strong command of CSA (Computer Software Assurance) principles Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+). Proven ability to write and manage valida

Easy Apply

Contract

Loftware Spectrum Technical Lead

Remote

•

Today

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

Easy Apply

Third Party, Contract

Depends on Experience

Field Service Engineer - Southeast

Remote or North Carolina

•

Today

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? As a LenSx Field Service Engineer, you will support Alcon equi

Full-time

Placement Role - Senior Technical Architect Algo Design for Clinical Imaging with AWS and AI/ML exp- Remote

Remote

•

25d ago

Our Client is looking for a Senior Technical Architect Algo Design with clinical imaging experience - Remote. Please review the JD. Role: Senior Technical Architect Algo Design for Clinical Imaging with AWS and AI/ML exp- Remote (Remote) Duration: 12-18+ Months Note: Need consultants with Healthcare Domain exp. JOB DESCRIPTION: Responsibilities: Strong hands-on architecture experience with AWSservices including compute, storage, networking, IAM, API management, containers, serverless, monitori

Easy Apply

Contract

Depends on Experience

Director of AI Engineering

Remote or Pasadena, California

•

Today

Director/Sr Director, AI Engineering (Remote, Full-Time) Join Vita Global Sciences, an innovative leader at the intersection of AI technology and life sciences, driving next-generation clinical data solutions. This is a fully remote, full-time opportunity to own the end-to-end AI/ML engineering strategy, leading advanced biometrics and clinical automation platforms with a global impact. Are you passionate about building scalable, production-level AI platforms in the life sciences space? Vita G

Easy Apply

Full-time

Loftware Spectrum Technical Lead / Solution Engineer

Remote

•

11d ago

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing

Easy Apply

Contract

Depends on Experience

Clinical Data Enablement

Remote

•

10d ago

Role: Clinical Data Enablement - Senior Manager Job Location: USA (Remote) Objective / Purpose: The Clinical Data Enablement Senior Manager is responsible for operating and continuously improving end-to-end clinical data pipelines across cloud-based data lake and data warehouse environments. This role builds scalable ingestion and transformation capabilities, partners closely with internal stakeholders and external vendors, and ensures reliable, compliant delivery of clinical data products to d

Easy Apply

Full-time

Depends on Experience

Sr. Clinical Developer/ SME (R+Clinical)

Remote or Hybrid in Tampa, Florida

•

9d ago

Hi, Job DetailsPosition: Senior Clinical Developer/SME (R + Clinical)Location: Anywhere on the U.S. East CoastExperience Required: 8+ years of deep R programming experiencePrimary Skills: R, Pharmacokinetics (PK/PD), Clinical Data Processing, CDISC SDTM/ADaMKey Technologies: R Shiny, tidyverse, data.table, PKNCA, mrgsolve, rxode2Clinical Modeling Tools: NONMEM, Monolix, Phoenix WinNonlinReporting Tools: R Markdown, QuartoWork Arrangement: HybridRole OverviewWe are seeking an experienced Senior C

Easy Apply

Third Party, Contract

65 - 70

Senior Manager, AI Innovation and Strategy - Life Sciences - Remote

Remote or Eden Prairie, Minnesota

•

Today

Optum Insight is improving the flow of health data and information to create a more connected system. We remove friction and drive alignment between care providers and payers, and ultimately consumers. Our deep expertise in the industry and innovative technology empower us to help organizations reduce costs while improving risk management, quality and revenue growth. Ready to help us deliver results that improve lives? Join us in making healthcare work better for everyone through people-led, res

Full-time

USD 112,700.00 - 193,200.00 per year

Senior Manager IT Manufacturing Applications

Remote or San Diego, California

•

Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 141,800.00 - 236,400.00 per year

Gxp jobs in Montpelier, VT 05602, USA