FDA Jobs in Seattle, WA

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

Jobot

US

Full-time

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: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing

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

Jobot

US

Full-time

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: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing

Lead IT Validation Consultant

Amaze Systems Inc

New York, USA

Contract, Third Party

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used

LIMS and QC Applications Consultant

Expedite Technology Solutions

Remote or Bridgewater, New Jersey, USA

Full-time, Contract

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

Document Management Specialist | Remote | Contract

Walker Healthforce

Remote

Contract

Document Management Specialist | Remote | Contract Walker Healthforce is seeking a Document Management Specialist with +4 years of experience. This is a contract opportunity. CORE REQUIREMENTS:An A.A. in Business or English (or related) with four (4) years of experience OR Bachelor of Arts degree.Strong writing skills with good grammar.Attention to detail.Able to work on multiple documents in parallel.Able to create simple forms and templates.Must be able to use MS Office tools and interact with

Direct Client - Quality Assurance Specialist (food or beverage manufacturing QA)

ChaTeck Incorporated

Seattle, Washington, USA

Contract, Third Party

Role: Direct Client - Quality Assurance Associate (food or beverage manufacturing QA) Location: Seattle, WA (Hybrid Tuesday, Thursday, the third day is flexible based) Duration: 12+ Months Job description "Implementing and auditing the manufacturing quality strategy, food safety, process and program quality and regulatory compliance to ensure the continuous supply of safe, wholesome and premium quality products to customers Tops Skills Needed Top Candidate Skills & How Applied Years of Ex

Sr. Principal Software Quality Engineer

Katalyst Healthcares and Lifesciences

Bellevue, Washington, USA

Full-time

Responsibilities: Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards. Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls. Lead software risk management (RMF), including risk evaluation, control, and mitigation. Drive Secure Product Development Framework (SPDF) and software security best practices. Support Agile software development teams, ensuring regulatory and quality compli

RTA Posted Job Description

Russell, Tobin & Associates

Redmond, Washington, USA

Contract

Our client, a (Tech industry), is looking to hire a (Environmental, Health, and Safety (EHS) Engineer) in (Redmond, WA).Title: Environmental, Health, and Safety (EHS) Engineer Duration: 10 Weeks Contract Location: Onsite, Redmond, WA Pay range: $80-90/hr. on W2 (DOE) Start Date: ASAP Responsibilities * Assist hardware teams and EHS safety leads in reviewing facilities for radiation and laser safety compliance * Analyze safety hazards, assist in creating requirement specifications for hardware p

Sr. TPM, Amazon Private Brands

Amazon Stores

Seattle, Washington, USA

Full-time

The Team: Private Brands is a highly-visible, fast-growing business within Amazon. We have a unique business and obsess over quality and building global brands our customers love. We aspire to be part of our customers? everyday lives by offering them unique products at compelling prices backed by Amazon?s strong customer obsessed reputation.The Role: We are looking for an exceptional Senior TPM to help build a Product Lifecycle Management (PLM) solution for Global Private Brands. Product develop

Verification Test Equipment Engineer

Philips North America

Bothell, Washington, USA

Full-time

Job Title Verification Test Equipment Engineer Job Description Verification Test Equipment Engineer (Bothell, WA) This is an exciting opportunity to join the Oral Healthcare team as a Verification Test Equipment Engineer, contributing to the development of next-generation Sonicare products. In this fast-paced role, you will support Systems Engineering and the Test & Verification Lab by ensuring that product testing equipment is designed, maintained, and optimized to effectively verify that pr

SAP GTS Business Function Implementation Lead (Remote Work)

Source Code Technologies LLC

Remote

Contract, Third Party

We are seeking an experienced SAP GTS Consultant with expertise in Global Trade Services (GTS), including full lifecycle implementations and hands-on configuration in SAP GTS E4H. The ideal candidate will have deep functional knowledge of compliance management, customs processes (exports/imports), and GTS master data, particularly in trade between the Dominican Republic (DR) and the US.This is a client-facing, lead role requiring strong project leadership, ability to drive results, and hands-on

IT Validation Consultant

Unicorn Technologies LLC

Remote

Contract, Third Party

Title: IT Validation Consultant with experience in Clinical Research Organisation/ Pharmaceutical/Biotech companies Duration: Contract Work Location: Remote Notes: Prior experience in CROs, clinical research organisations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. We are seeking an experienced I

Compliance Specialist V (Environmental, Health, and Safety Engineer)

OrangePeople

Redmond, Washington, USA

Contract

OrangePeople, we're more than a consulting firm-we're a people-first, high-touch organization committed to delivering transformative technology solutions with integrity and passion. Currently, we are seeking an Environmental, Health, and Safety (EHS) Engineer with an emphasis on Laser Safety in Redmond, WA. The EHS Engineer role will primarily support the radiation and laser safety team through area assessments, evaluating equipment purchase requirements, reviewing R&D experiments, and performi

Senior Biostatistician: Pharma experience / Remote

Biogensys

Remote

Contract

Biogensys is currently hiring Senior Biostatistician with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Senior Biostatistician: Pharma experience / Remote- At least 9-10 years of 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 analysis

SAP project Manager - Supply chain

ARK Infotech Spectrum

Remote or Plano, Texas, USA

Contract, Third Party

Role: SAP project Manager - Supply chain Location: Remote -End-to-end project execution from initiation to closure across supply chain and digital integration initiatives (5+ years). - Work with functional and technical teams on SAP supply chain modules (MM, WM, SD, PP). Lead requirement analysis, UAT, and cutover planning (4+ years in SAP projects). - Lead data migration and interface projects using ETL tools, middleware, APIs, or EDI systems (3+ years). - Experience in pharmaceutical/life scie

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

New Jersey, USA

Third Party, Contract

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR

Document Management Specilist (W2 Only - 100% Remote)

Performix Business Services, LLC

Remote or Rochester, Minnesota, USA

Contract

Learn Division of Engineering tools and expectations.Document controls system (SolidWorks PDM) structure, navigation, and use.Engineering change order process.Document templates.Assist with document revisions from annual review. For each document:Accept redlines from document owner (facilitate review?).Review documents and suggest further incremental improvements.Verify reference documents section.Documents referenced in text are included in reference section.Documents in reference section exist

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's

CQV Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical

Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

Biogensys

Remote

Contract

Biogensys is currently hiring a Senior SAS programmer with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Statistical Programmer II: Pharma experience/Remote At least 7-8 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