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Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Remote

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Today

Sr Mechanical/Process Design Engineer - Technical Lead (Cleanrooms/Pharma/Healthcare/cGMP) - Remote (East Coast Preferred) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Des

Full-time

USD 115,000.00 - 150,000.00 per year

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Remote

•

Today

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Design/Build Solutions to meet our Clients

Full-time

USD 115,000.00 - 150,000.00 per year

Business Analyst

Remote or Hybrid in Pittsburgh, Pennsylvania

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Today

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil

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Contract

$43 - $48 hr

Computer System Validation Lead

Remote

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3d ago

Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA Gu

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Third Party, Contract

Depends on Experience

LIMS and QC Applications Consultant

Remote or Hybrid in Bridgewater, New Jersey

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Today

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an

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Full-time, Contract

BASED ON EXPERIENCE

Statistical Programmer

Remote

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3d ago

Statistical Programmer Remote Duration: 12+ Months Rate: DOE Key responsibilities At least 5 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.Collaborate with statisticians and data managers to define dataset specifications and outputsEnsure compliance with internal SOPs, CDISC standards,

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Contract

Depends on Experience

Clinical Data standards - Python and AI,Ml

Remote

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Today

Job Title: Clinical Data standards - Python and AI,ML Location: 100% Remote Job Type: Contract Experience Level: 10 Years Industry: Pharmaceutical / Life Sciences MUST Have : Regulatory submission processes and FDA expectations for e-submissions About the Role We are seeking a highly skilled Python Developer with deep experience in clinical data standards (SDTM/CDISC) and a strong interest in AI/ML-driven automation. This role is ideal for someone with a pharmaceutical industry background who c

Easy Apply

Contract

Depends on Experience

LIMS - Laboratory Information Management Systems

Remote

•

Today

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce

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Contract, Third Party

Depends on Experience

Production Technician III - SSMG - FP - US

Portland, Oregon

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Today

JOB SUMMARY: The Production Technician role is essential for supporting the operations team and is responsible for planning and performing highly diversified duties to include installing, moving, repairing and preventive maintenance on production equipment throughout the facility. Perform 5S and Lean manufacturing activities including material handling improvements, production line configuration, and safety procedures. This role must use and exemplify industry leading maintenance practices an

Full-time

Production Technician III - SSMG - FP - US

Portland, Oregon

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Today

Full-time

Director, Drug Product Quality Assurance

Hillsboro, Oregon

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Today

Job DescriptionHillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Quality organization at HTO comprises Quality Assurance, Quality Systems & Compliance, Quality Control, and Quality Engineering & Validation. Together, we produce millions of units of life-saving medicine every year to patients around the world. The Opportunity: In this exciting role, you

Full-time

Manufacturing Engineer I - Onsite Wilsonville, OR

Wilsonville, Oregon

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Today

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview The successful candidate will efficiently provide high-quality engineering solutions to complex manufacturing and business problems. The Manufacturing/Process Engineer will drive improvement using industry best practices and standardize work. Work will be completed according to TE Connectivity's SOPs within an ISO 13485 environm

Full-time

USD 70,200.00 - 87,700.00 per year

Manufacturing Engineer II - Onsite Wilsonville OR

Wilsonville, Oregon

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Today

Full-time

USD 83,100.00 - 103,800.00 per year

Sr. Regulatory affairs Consultant-W2 ONLY

Remote

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4d ago

Sr. Regulatory affairs Our client is a rapidly expanding biotech company based in China that recently partnered with a major pharmaceutical company for research collaboration efforts, in hopes of discovering and developing novel oral drug candidates across multiple therapeutic indications (oncology, immunology, etc.) Our client is looking to bring on a Senior Regulatory Affairs Consultant (Senior/Director Level), who will provide strategic regulatory guidance as the client navigates the regulato

Easy Apply

Contract

Depends on Experience

Technical Lead AWS

Remote

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Today

Job Title: Technical Lead AWS (AI/ML Experience Preferred) Client: U.S. Food and Drug Administration (FDA) Position Type: Full-time | Permanent Location: 100% Remote Job Summary: We are seeking a highly skilled Technical Lead to support our ongoing initiatives with the FDA. The ideal candidate will have a strong technical background, leadership experience, and a passion for innovation, with machine learning (AI/ML) experience being a strong plus. This is a long-term, fully remote opportunity wi

Easy Apply

Full-time

Depends on Experience

Instrumentation Technician (Contractor)

Hillsboro, Oregon

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Today

Job DescriptionAt Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decisions and action, we believe that good business means a better world. The focus of Genentech Hillsboro Tech

Full-time

Compensation information provided in the description

Senior Biostatistician

Remote

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3d ago

Senior Biostatistician Remote Duration: 12+ Months Rate: DOE At least 8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (CDISC, ICH, FDA/EMA gu

Easy Apply

Contract

Depends on Experience

Senior Biostatistician

Remote

•

3d ago

Position: Senior Biostatistician Location: Remote/EST time zone Contract- Long termAt least 6-8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (

Easy Apply

Contract

$70 - $75

Data Science/ML Engineer

Remote

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Today

We are seeking a highly skilled Senior Machine Learning Engineer to join the Foundational Data Analytics (FDA) Program, a strategic initiative focused on building a modern, intelligent data ecosystem. This role will lead the design, development, and deployment of machine learning models that support enterprise-wide analytics, predictive insights, and healthcare transformation. FDA Program Objectives: Single Source of Truth (SSOT): Build standardized, high-quality data infrastructure ensuring con

Easy Apply

Contract

Depends on Experience

Statistical Programmer

Remote

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3d ago

Job Title: Statistical Programmer Location: Remote Key Responsibilities Develop, validate, and maintain SAS programs for statistical analysis, regulatory submission, and reporting deliverables. Create analysis datasets (ADaM) and tables, listings, and figures (TLFs) for clinical trial data analysis. Collaborate with statisticians and data managers to define specifications for datasets and statistical outputs. Ensure compliance with CDISC standards, internal SOPs, and regulatory guidelines (FDA,

Easy Apply

Contract

Depends on Experience

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