FDA jobs in Baltimore, MD

Hybrid in College Park, Maryland

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10d ago

Job Title:Program /Project Manager(Public Healthand/or Pharmaceutical Experience) Overview: We are seeking an experienced Program/Project Manager to support a federal government contract involving Public health and data-focused system modernization. The ideal candidate will have prior experience working inPublic Health,pharmaceutical, orlife sciences domain. This individual will play a key role in managing project activities, coordinating technical teams, and engaging with stakeholders to ensure

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Full-time

Depends on Experience

SAP Test Automation Delivery Lead

Remote or Hybrid in California

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Today

Job Title: SAP QA Automation ( Tosca ) Lead Duration: 18 Months+ Location PST - 100% Remote Exp. Level: 10+ years Job Description Our client is looking for a TOSCA certified automation engineer who has experience to Lead automation strategy and delivery across SAP implementation projects, ensuring consistency and compliance (GxP, FDA). Client is looking for Pharma / BioTech domain in background. Key Responsibilities: Lead automation strategy and delivery across SAP implementation projects, ensu

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Full-time, Contract

BASED ON EXPERIENCE

Supply Chain Project Manager

Remote

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6d ago

Job Title: Project / Product Manager -Supply Chain SME Location: Remote Duration: 6+ Months Job Description: Key Responsibilities: Work with the Director, Product and Technology teams to lead and manage end-to-end project execution from initiation to completion, ensuring projects are delivered within scope, budget, and timeframe. Collaborate with the various stakeholder groups to define project objectives, requirements, and success criteria, aligning them with the organization objectives. Devel

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Contract

Depends on Experience

Statistical Software Configuration Specialist (Statistica TIBCO)

Remote or Hybrid in Vacaville, California

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Today

Statistical Software Configuration Specialist (Statistica TIBCO) Vacaville, CA / A hybrid model (once or twice in the office) / Remote Duration: - 6-12 Months+ For a "Statistica Software configuration specialist" role, which likely involves both data analytics and potentially on-site manufacturing support or collaboration, a hybrid model (once or twice in the office) is a probable arrangement. Statistical Software Configuration Specialist (Statistica TIBCO) Position Overview The Statistical Soft

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Contract, Third Party

Depends on Experience

SAP PPQM PTS Consultant Remote

Remote or Atlanta, Georgia

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Yesterday

Job Id: #CGEMJP00321513 Title: SAP PPQM PTS Consultant Location: Remote Duration: 12+ Months Position Summary: Job Role and Responsibilities: We are looking for a highly skilled Senior SAP PPQM Consultant with over 6 years of experience in SAP Production Planning (PP) and Quality Management (QM) modules, specifically within the pharmaceutical industry. The ideal candidate will have a deep understanding of GxP compliance, regulatory requirements, and validation documentation. This role involv

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Full-time, Part-time, Contract, Third Party

Full Stack Engineer

Remote

•

Today

Full Stack Engineer - Remote (EST)Responsibilities Collaborate with your team to design, develop, test, deploy, and maintain secure, compliant SaaS solutions Build and enhance software features to address customer challenges and improve user experience Drive continuous improvement efforts and support CI/CD processes throughout the development lifecycle Promote and implement automation to streamline workflows, reduce manual effort, and ensure consistency Engage in all stages of product deve

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Full-time

$135000

Sr. Manager Engineering

Sparks, Maryland

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Today

Job Description Summary Senior Manager of Manufacturing Engineering will have plant-wide leadership responsibility for planning, coordinating, and managing activities and initiatives that have broad organizational impact focusing on Engineer activities. Responsible for managing a manufacturing plant's sustaining engineering, process engineering and overall platform manufacturing engineering support. Job Description We are the makers of possible BD is one of the largest global medical technolog

Full-time

USD 143,900.00 - 237,600.00 per year

Regulatory Strategy Consultant

Remote or Hybrid

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Today

Position: Regulatory Strategy Advisor (FDA Approval Process) Location: Remote Duration: 6-12 months (fractional engagement) <>Overview We are seeking an experienced Regulatory Strategy Advisor to guide a medical technology organization through the FDA approval process for a neuro-electric medical device. This role is critical in ensuring compliance with FDA guidelines, minimizing organizational risk, and providing strategic oversight throughout the regulatory journey. <>Key Responsibilities

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Contract

$100 - $250 per hour

Senior Software Test Engineer

Sparks, Maryland

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Today

Job Description Summary As a Senior Software Test Engineer at BD, you will play a critical role in advancing our vision of streamlining and innovating diagnostic technologies with a strong focus on customer experience and product quality. You will join a dynamic Agile team focused on developing a robust middleware platform that bridges medical devices with hospital Laboratory Information Systems (LIS). Job Description We are the makers of possible BD is one of the largest global medical techno

Full-time

Senior Director of Facilities & Engineering

Cockeysville, Maryland

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Yesterday

Job Overview: In this role the Senior Director, Facilities & Engineering will be responsible for the Engineering, Maintenance, and Site Services for the Pharmaceutics International Inc., ('Pii'), Holly Mount, MD Facilities, which includes the four buildings owned or leased by Pii (collectively 'the Site'). The Senior Director, Facilities & Engineering provides life cycle asset and facilities management leadership for the Site by implementing strategies that assure sustainable, reliable and rep

Full-time

Regulatory System Manager

Remote

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18d ago

Summary: We are seeking a highly technical and detail-oriented Regulatory Systems Manager to oversee our digital compliance and submission activities. This role is critical for managing our interactions with global health authorities, including the FDA and the EU's EUDAMED database, through modern electronic data exchange protocols. Key Responsibilities:EUDAMED Management: Serve as the company's subject matter expert (SME) for the EUDAMED database, responsible for data submission, device registr

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Contract

$80+

Salesforce Solution Architect

Remote

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26d ago

Job Title: Solution Architect Salesforce & Honeywell TrackWise Digital Location: Remote Experience: 10+ Years Position Overview: We are seeking an experienced Solution Architect with strong expertise in Honeywell s TrackWise Digital platform to lead architecture, design, and integration for digital quality systems. The ideal candidate will drive end-to-end solution design and ensure seamless alignment between Salesforce, TrackWise Digital, and enterprise applications. Key Responsibilities: Solu

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Contract

Depends on Experience

CSA Auditor, TraceLink

Remote

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20d ago

We are seeking a Computerized System Assurance (CSA) Auditor with deep experience in TraceLink and GxP-regulated environments to ensure the compliance, validation, and lifecycle integrity of computerized systems supporting serialization, traceability, and supply chain management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory expectations for data integrity and system validation. Key Responsibilities: Plan, conduct, and report CSA aud

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Contract

85 - 90

Program & Technical Advisor (Sr. Consultant/Managing Consultant/Associate Director)

Maryland

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Today

Job Family: Strategy & Transformation Consulting Travel Required: Up to 25% Clearance Required: Ability to Obtain Public Trust What You Will Do The Program & Technical Advisors delivers specialized scientific and programmatic expertise in areas related to medical countermeasures research and development. These services are essential for advancing efforts in biotechnology and biopharmaceuticals, particularly in addressing public health impacts from chemical, biological, radiological, and nucle

Full-time

USD 98,000.00 - 163,000.00 per year

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

Canada Role || SAP Project Manager

Remote

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Today

We are seeking a dynamic and results-driven Project Manager Supply Chain with strong leadership, multitasking, and organizational skills. The ideal candidate will have extensive experience in SAP ERP, data integration, and manufacturing and supply chain operations, preferably within the pharmaceutical or life sciences domain. This role will manage digital supply chain transformation initiatives, collaborating with global IT, operations, and quality teams to ensure project delivery excellence, re

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Contract, Third Party

Depends on Experience

Business Analyst - Pharmacy or PBM experience

Remote

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10d ago

Urgently looking to hire Business Analyst- Fulltime or Contract About the Role We are seeking an experienced Business Analyst with a strong background in pharmacy operations or pharmacy benefit management (PBM), or specialty pharmacy products. The Business Analyst will play a critical role in bridging business needs with technical solutions, ensuring that systems and processes align with regulatory requirements and support patient-centered pharmacy services. Key Responsibilities Partner with bus

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Full-time

Depends on Experience

Senior Software Test Engineer- Embedded Systems /Medical Devices (Hybrid)

Remote or Portage, Michigan

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Today

Work Flexibility: Hybrid or Onsite The Senior Software Test Engineer - Embedded Systems/Medical Devices will be responsible for leading the verification and validation (V&V) of embedded software in our Class I, II, & medical devices. This role is critical to ensuring our products meet the highest standards of quality, safety, and regulatory compliance. The ideal candidate will bring deep expertise in embedded systems, test automation, and software testing within regulated environments (IEC 623

Full-time

Staff Engineer - Software Quality - Indianola, Pa (Hybrid)

Remote or Indianola, Pennsylvania

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Today

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of br

Full-time

USD 97,264.00 - 145,897.00 per year

Sr. Software Engineer

Remote or Salt Lake City, Utah

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Today

Sr. Software Engineer (onsite or remote depending on location) Salt Lake City, UT or Denver, CO Direct Hire Pay: $140k-$160k Job Description: Our client is looking for a Sr. Software Engineer. As part of the team working in R&D, you will work across multiple languages and frameworks, including React Native, React, TypeScript, JavaScript, Python, and AWS (Flutter is a plus). You'll operate within a regulated SDLC (FDA, 62304/82304) emphasizing automation, testing, observability, cybersecurity,

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Full-time

USD 140,000.00 - 160,000.00 per year

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FDA jobs in Baltimore, MD, USA