21 CFR Part 11 jobs in Baltimore, MD

Sparks, Maryland

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Today

Job Description Summary The Staff Quality Engineer I - Software is the emerging Subject Matter Expert that is accountable to participate on project teams and manage Quality function deliverables. This position will work with new or transferred products to administer the design control and validation elements of the Quality System to ensure regulatory compliance and robust product/process design for new software products and maintenance of existing software products. The position is accountable

Full-time

USD 113,400.00 - 186,900.00 per year

Sr. Regulatory Specialist SaMD / 510(k) / Medical Device | Contract | Remote

Remote

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2d ago

Sr. Regulatory Specialist SaMD / 510(k) / Medical Device Location: Remote - (Philadelphia, PA must work in EST time zone) Duration: Long Term Contract About the Role:We are seeking a Senior Regulatory Specialist with deep expertise in Software as a Medical Device (SaMD) and 510(k) submissions to support regulatory strategy and compliance for next-generation digital health and AI-enabled medical products.This role will partner closely with cross-functional teams (R&D, Quality, and Clinical) to en

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Contract

Depends on Experience

TIBCO Spotfire Developer

Remote

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4d ago

Title: TIBCO Spotfire Developer (Life Sciences Domain)Location: Remote - New JerseyEmployment Type: Contract Were looking for an experienced TIBCO Spotfire Developer with strong hands-on expertise in data visualization, analytics, and integration within the Life Sciences or Pharmaceutical domain. The ideal candidate will have experience developing interactive dashboards, integrating multiple data sources, and ensuring compliance with GxP and 21 CFR Part 11 standards. Key Skills:Spotfire, IronPyt

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Part-time, Third Party

Depends on Experience

LIMS Consultant

Remote

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3d ago

We are seeking a LIMS Specialist to manage, configure, and support our Laboratory Information Management System (LIMS). The role ensures smooth lab operations, data integrity, and regulatory compliance across all testing workflows. Key Responsibilities: Configure and maintain LIMS master data, workflows, and user access.Support implementation, validation (IQ/OQ/PQ), and system upgrades.Troubleshoot issues and coordinate with IT/vendors for resolution.Ensure compliance with GxP, 21 CFR Part 11, a

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Third Party, Contract

$60 - $70

Senior CSV Engineer

Remote or Massachusetts

•

Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Empower CDS Administrator

Remote

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4d ago

Empower CDS Administrator Direct-Hire / FTE with WinWire REMOTE / Work From Home We are seeking an experienced professional to manage and support Waters Empower Chromatography Data System (CDS), oversee laboratory instrument integration, perform troubleshooting, and ensure system compliance with GxP and 21 CFR Part 11 regulatory requirements. The role also involves Computer System Validation (CSV), administration, and continuous improvement of laboratory informatics systems. Skills/Experience 3

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Full-time

Depends on Experience

Validation/Test Lead & Testers Regulated Systems (Veeva / SQM / QRM)

Remote

•

Yesterday

Job Title: Validation/Test Lead & Testers Regulated Systems (Veeva / SQM / QRM) Position Summary We are seeking experienced Validation/Test professionals-including a Validation/Test Lead and multiple Testers-to support a large-scale Veeva Quality implementation within a regulated (GxP) environment. The ideal candidates will have hands-on experience with Computer System Validation (CSV) processes, creation and execution of regulated validation deliverables, and a strong understanding of Suppli

Contract, Third Party

Project Manager Regulated Systems (Veeva Implementation)

Remote

•

Yesterday

Job Title: Project Manager Regulated Systems (Veeva Implementation) Position Summary We are seeking an experienced Project Manager with a strong background in regulated systems and vendor/IT coordination to lead the implementation and enhancement of Veeva applications (Vault QMS, RIM, QualityDocs, etc.). The ideal candidate will have demonstrated success managing projects in GxP-regulated environments, ensuring compliance, alignment with business objectives, and timely delivery of system soluti

Contract, Third Party

TIBCO Spotfire Developer

Remote

•

Yesterday

Solution IT Inc. is looking for TIBCO Spotfire Developer for one of its clients in Remote Job Title: TIBCO Spotfire Developer Summary We are seeking an experienced TIBCO Spotfire Developer with hands-on expertise in developing advanced analytics and visualization solutions for Life Sciences clients, particularly in Pharma R&D, Clinical, Regulatory, or Commercial data environments. The ideal candidate will be responsible for designing and implementing interactive dashboards, integrating data f

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Full-time, Contract, Third Party

Clinical Domain SME || NC

Remote or Hybrid in Cary, North Carolina

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2d ago

Job Title: Clinical Domain SME Life Sciences ConsultingLocation: NC Position SummaryClinical Domain Subject Matter Expert (SME) to lead strategic transformation initiatives across the life sciences ecosystem. This senior-level role demands deep expertise in clinical development spanning pharmaceuticals, biotech, medical devices, CROs, and SMOs and combines functional leadership with digital innovation, automation, analytics, and AI/GenAI capabilities. The SME will collaborate with executive and

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Contract, Third Party

Depends on Experience

Organizational Change Management (OCM)

Remote

•

Yesterday

Job Title: OCM / Training Lead & Trainers Regulated Systems (Veeva Quality Transformation) Position Summary We are seeking an experienced Organizational Change Management (OCM) / Training Lead and supporting Trainers to drive the change, communication, and learning strategy for a large-scale Veeva Quality transformation program. The OCM/Training team will play a critical role in ensuring business readiness, user adoption, and sustained process excellence across global functions. The ideal can

Contract, Third Party

R&D Business Systems Lead (BSA/PM) with Life Sciences -GxP Expereince

Remote

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30+d ago

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: R&D Business Systems Lead (BSA/PM) Location: Cambridge, MA (Remote) Duration: 12+ months Qualifications & Experience Required: 8+ years of combined experience in Life Sciences IT, including:Minimum 4 years in a GxP-regulated system administrator or support capacity.Minimum 4 years in project management, delivering cross-functional systems in R&D or Clinical domains.Str

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Contract

Depends on Experience

Senior Staff Software Advance Quality Engineer (REMOTE)

Remote or Portage, Michigan

•

Today

Work Flexibility: Remote or Hybrid or Onsite Senior Staff, Software Quality Assurance Engineer - Remote Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with internal procedures and regulatory standards (e.g SOC 2, ISO, FDA and HIPAA)

Full-time

USD 115,600.00 - 245,800.00 per year

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Application Analyst IV

Remote

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5d ago

Immediate need for a talented Application Analyst IV. This is a 12 months contract opportunity with long-term potential and is located in U.S(Remote). Please review the job description below and contact me ASAP if you are interested. Job ID:25-90333 Pay Range: $60 - $70/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: The ideal candidate will have strong progr

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Contract

$60 - $70

Sr. IT Program Manager

Remote or Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Uncover a remarkable opportunity at Thermo Fisher Scientific Inc. to push global advancements in health, cleanliness, and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team, guiding ambitious IT projects that enhance quality, compliance, and supply chain operations within our Contract Development and Manufacturing Organization (CDMO). Argument Development & Case Creation Collaborate

Full-time

Systems Administrator

Remote or Tennessee

•

Today

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives

Full-time

Controls Engineer (DeltaV)

Remote

•

Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

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Full-time

USD 120,000.00 - 160,000.00 per year

Cybersecurity Architect

Remote or Cleveland, Ohio

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Today

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day. We all have the power to help, heal and change lives - beginning with our own. That's the power of the Cleveland Clinic Health System team, and The Power of Every One. Job Title Cybersecurity Architect Location Cleveland Facility Remote Location Department Cybersecurit

Full-time

Director, R&D Data Science - Patient Mastering, Consent & Preference Management

Remote or Hopewell Township, New Jersey

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Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 160,000.00 - 276,000.00 per year

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21 CFR Part 11 jobs in Baltimore, MD, USA