FDA Jobs in Baltimore, MD

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W2 only Software Quality Assurance Consultant - EST/CST Only - regulatory affairs Medical Devices, software development life cycle risk management and configuration management FDA

APN Software Services, Inc

•

Remote

Contract

Please contact Abdul on "" OR email me at "" Job Responsibilities: Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements. 2. Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test pl
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Posted 8 days ago | Updated 2 days ago

LIMS and QC Applications Consultant

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
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Posted 60+ days ago | Updated moments ago

Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)

Amerit Consulting

•

Remote

Contract

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Software Program Manager NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099) Candidate must be authorized to work in USA without requiring sponsorship Position: Medical Devices Software Program Manager(Job Id - # CFNJP00051124) Location: San Diego CA 92130 (Remote) Duration: 6 months + Contract to
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Posted 10 days ago | Updated 1 day ago

Business Quality Assurance (BQA)

Activesoft, Inc.

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Remote

Contract

Mandatory Skills & Qualifications: Strong knowledge in GMP, cGMP, and regulatory standards:21 CFR Part 1121 CFR Part 21021 CFR Part 211ICH Q7Experience facing FDA audits at pharmaceutical manufacturing sitesHands-on experience with manufacturing processes, CAPAs, deviations, etc.Lead Auditor or any other compliance certifications (preferred)
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Posted 26 days ago | Updated 1 day ago

PTC Arena Consultant

Teknikoz

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Remote

Third Party, Contract

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an
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Posted 2 days ago | Updated 2 days ago

Sr Validation Engineer

Katalyst Healthcares and Lifesciences

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Columbia, Maryland, USA

Full-time

Responsibilities: Responsible for preparing, executing commissioning and qualification documents for a variety of utilities, facility, and process equipment. Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team. Excellent leadership skills include the ability to simultaneously organize, and successfully execute
Posted 24 days ago | Updated 3 hours ago

Microsoft Dynamics CRM Developer

Beacon Systems, Inc

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Towson, Maryland, USA

Third Party, Contract

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Microsoft Dynamics CRM Developer Location: Towson, MD 21204 Duration: 12 Months plus
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Posted 2 days ago

Process Engineer

Becton Dickinson & Company

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Sparks, Maryland, USA

Full-time

Job Description Summary The Process Engineer supports the key business objectives of the assigned plant (Growth, Profitability, and Innovation). Through production support and assigned plant specific projects, the associate drives activities to deliver upon these objectives. Through the execution of deliverables, the Engineer 2 is familiar with and capable of performing in many key areas defining the duties and responsibilities of this role. Job Description We are the makers of possible BD is
Posted 43 days ago | Updated 3 hours ago

Remote Senior Appian Developer

Computer Merchant, Ltd., The

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Remote or Rockville, Maryland, USA

Full-time

JOB TITLE: Senior Appian Developer JOB LOCATION: Remote WAGE RANGE*: $75HR TO $80HR JOB NUMBER: 25-02929 REQUIRED EXPERIENCE: MUST OBTAIN A PUBLIC TRUST Skills: Appian BPM, Application Design, Software Development Experience: 10 + years of related experience JOB DESCRIPTION The Food and Drug Administration (FDA) is the federal agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devic
Posted 2 days ago | Updated 11 hours ago

Regional Sales Manager - Northeast US

GEA

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Columbia, Maryland, USA

Full-time

GEA Group, founded in Germany in 1881, is a global leader in engineering solutions, serving industries such as food and beverage, pharma, dairy, and more. With over 18,000 employees worldwide and a strong U.S. presence since 1929, GEA combines the heritage of a well-established company with the innovation of a forward-thinking industry leader. At GEA, we're not just building equipment, we're building lasting careers with an average employee tenure range from 5 to over 11+ years, reflecting the s
Posted 23 days ago | Updated 22 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract , remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Acti
Posted 1 day ago | Updated moments ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract, remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Active
Posted 2 days ago | Updated moments ago

Systems Support Specialist I

Becton Dickinson & Company

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Sparks, Maryland, USA

Full-time

Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find progressive solutions that turn dreams into possibilities. We believe that the human elem
Posted 34 days ago | Updated 3 hours ago

Drug Safety Scientist

Sunrise Systems, Inc.

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Remote

Contract

Job Title Drug Safety Scientist Job ID: 25-08470 Location: 100% Remote (Candidates should be in EST only) Duration: 12 months on W2 Contract Summary: Seeking an experienced Drug Safety Scientist with 5+ years in pharmacovigilance to support regulatory safety reporting and risk management. Must hold a Bachelor's/Master s in Pharmacy, Biotechnology, or Chemistry. Key Responsibilities: Author safety reports (DSUR, PBRER, PADER)Support signal detection and safety data evaluationConduct literature
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Posted 5 days ago | Updated 1 day ago

Remote Senior QA Test Manger/QA Leader with Strong Healthcare Domain

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 Descriptions : We are looking for an experienced Senior QA Healthcare Manager/QA Leader 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: Lead and manage the QA t
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Posted 4 days ago

Senior Expert Physicist

Spar Information Systems

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US

Contract, Third Party

Looking for a Senior-Level Expert-preferably a scientist or physicist-with hands-on experience designing, developing, and troubleshooting magnetic tracking systems, especially in medical device or similar precision environments. Key Requirements: Domain-Specific Expertise Must have direct experience building and shipping magnetic tracking solutions-ideally used in catheter navigation, cardiac, gastrointestinal, or surgical tracking systems. Should be deeply familiar with electromagnetic field be
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Posted 8 days ago | Updated 5 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

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
Posted 24 days ago | Updated 3 hours ago

Oracle Field Service Cloud Consultant

Prutech Solutions

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Remote

Contract

Job Title: Oracle Field Service Cloud Consultant Duration: Full Time / Contract Location : Remote Required Skills/Experience: Bachelors degree in computer science, Information Technology, Engineering, or a related field.5+ years of experience in implementing and supporting Oracle's Field Service solutions.Strong understanding of and field service processes and best practices.Proven expertise in Oracle's E-Business Suite, Cloud, or other relevant Oracle products.Excellent analytical and problem-
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Posted 51 days ago | Updated 1 day ago

DeltaV Automation Engineer - Pharmaceuticals

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is hiring a DeltaV Automation Engineer for a growing BioPharma company located in Holly Springs, NC. The DeltaV Automation Engineer will be responsible for designing, developing, and maintaining automation systems for pharmaceutical manufacturing processes. This role requires expertise in Emerson DeltaV DCS (Distributed Control System), with a focus on process optimization, validation, and compliance with industry regulations. The DeltaV Automation Engineer can work remote, but w
Posted 8 days ago | Updated moments ago

Principal Product Security Engineer (REMOTE)

Stryker

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Remote or Portage, Michigan, USA

Full-time

Work Flexibility: Remote Product Security is driven to make healthcare better by ensuring that Stryker designs, develops, and maintains industry leading cyber secure products for our customers. We are seeking a highly skilled Secure Product Lifecycle Expert to ensure the security of our medical devices across their entire lifecycle. This role is critical in embedding robust security practices into our software development lifecycle (SDL), overseeing post-market security management, and integrat
Posted 6 days ago | Updated 3 hours ago