FDA Jobs in Ohio

1 - 20 of 78 Jobs

Lead IT Validation ConsultantJob Title - Lead IT Validation Consultant

Amaze Systems IncCompany Name - Amaze Systems Inc

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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

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

JobotCompany Name - Jobot

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

JobotCompany Name - Jobot

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Full-time

ChemistJob Title - Chemist

ITS Technologies, Inc.Company Name - ITS Technologies, Inc.

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Bowling Green, Ohio, USA

Full-time

Integrated Talent Strategies (ITS) is seeking a Chemist to work in the Perryburg, OH area. This is a direct hire position that offers a variety of great benefits, including health insurance, 401(k), and paid time off.Description Conducts research, formulation and experimentation for new product development and process improvement. Experience formulating coatings which may include floor, paint, or automotive at the bench. Product development experience working with marketing from concept through

LIMS and QC Applications ConsultantJob Title - LIMS and QC Applications Consultant

Expedite Technology SolutionsCompany Name - Expedite Technology Solutions

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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

Project EngineerJob Title - Project Engineer

JobotCompany Name - Jobot

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Ashland, Ohio, USA

Full-time

Project Engineering - Global Company - Top Tier Compensation, Benefits and PTO This Jobot Job is hosted by: Phil Carlier Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $120,000 - $160,000 per year A bit about us: Our client is a global leader in the Food & Beverage industry. They've been in business for over a century and offer top tier compensation, benefits, PTO and upward mobility. Due to the necessity of their industry they are always

Project EngineerJob Title - Project Engineer

JobotCompany Name - Jobot

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Wooster, Ohio, USA

Full-time

Project EngineerJob Title - Project Engineer

JobotCompany Name - Jobot

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Massillon, Ohio, USA

Full-time

Document Management Specialist | Remote | ContractJob Title - Document Management Specialist | Remote | Contract

Walker HealthforceCompany Name - Walker Healthforce

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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

SAP GTS Business Function Implementation Lead (Remote Work)Job Title - SAP GTS Business Function Implementation Lead (Remote Work)

Source Code Technologies LLCCompany Name - Source Code Technologies LLC

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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 ConsultantJob Title - IT Validation Consultant

Unicorn Technologies LLCCompany Name - Unicorn Technologies LLC

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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

SAP project Manager - Supply chainJob Title - SAP project Manager - Supply chain

ARK Infotech SpectrumCompany Name - ARK Infotech Spectrum

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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

Senior Biostatistician: Pharma experience / RemoteJob Title - Senior Biostatistician: Pharma experience / Remote

BiogensysCompany Name - Biogensys

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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

Principal Regulatory Consultant Dietary SupplementsJob Title - Principal Regulatory Consultant Dietary Supplements

Apptad IncCompany Name - Apptad Inc

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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)Job Title - Document Management Specilist (W2 Only - 100% Remote)

Performix Business Services, LLCCompany Name - Performix Business Services, LLC

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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) EngineerJob Title - Computer System Validation (CSV) Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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 EngineerJob Title - CQV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Validation EngineerJob Title - Validation Engineer

Merck KgaACompany Name - Merck KgaA

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Miamisburg, Ohio, USA

Full-time

Work Location: Miamisburg, Ohio Shift: No Department: LS-SC-PEMM Engineering & Maintenance Recruiter: Renay Middleton Hiring Manager: John Shay This information is for internals only. Please do not share outside of the organization. Your Role: In this role you will develop and execute validation protocols to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This role is crucial for maintaining the quality and integrity of manufacturing processes and produ

Remote QA Manager with Healthcare Payer and Claims expJob Title - Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)Company Name - Infinite Computer Solutions (ICS)

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Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Summary: We are looking for an experienced QA Healthcare Manager to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: we need someone who understand healthacre paye

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

BiogensysCompany Name - Biogensys

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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