21 CFR Part 11 jobs in Indiana

Indianapolis, Indiana

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Today

Job Description: Participates in fit gap analysis Process Modeling process standardization with Area lead Process SME Works with the lead RA to develop BB requirements Provide times, user story point estimates, and status for all stories assigned to them Authors and performers document supporting validation of EBRs Configures EBR in Development, Stage, and Production environments Address site-specific questions, use cases, and ER from Site EBR and PO Works across the teams to put requirements to

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Third Party

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

Remote

•

Yesterday

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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3d 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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2d 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

Validation Engineer

Indianapolis, Indiana

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Today

Responsibilities: Provide application/system validation expertise for standalone, enterprise, and integrated systems in a regulated (GxP) environment. Lead OT system qualification and validation, including Client/DCS integrated with manufacturing equipment. Support qualification activities in Radio Ligand Therapy (RLT) or critical dosage forms (preferred). uthor and review Validation Plans, Test Scripts/Protocols, and Validation Summary Reports. Ensure alignment with SDLC deliverables and IT Qua

Full-time

Senior CSV Engineer

Remote or Massachusetts

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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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3d 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

CSV Support Engineer

Greenfield, Indiana

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Today

Responsibilities: Empower Administration & Support. Manage user accounts, access rights, roles, and privileges in Empower. Perform system configuration, project management, and template/report customization. Provide day-to-day L2/L3 support for Empower users across QC/analytical labs. Instrument Integration & Troubleshooting. Integrate lab instruments (HPLC, UPLC, Dissolution, UV, etc.) with Empower. Troubleshoot connectivity, data acquisition, and communication issues between instruments and C

Full-time

Empower CDS administration / support

Greenfield, Indiana

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10d ago

Job Title: Empower CDS administration/ supportLocation: Greenfield, INDuration: Long term contract/Full time Open Educational Qualification*Any Bachelor's DegreeExperience Range8-10 yearsPrimary (Must have skills)* - To be Screened by TA Team3+ years of hands-on experience in Empower CDS administration and support. 3+ years of experience on HPLC/UPLC and other analytical instrument integration. 3+ years of experience on Computer System Validation (CSV) and preparation of validation deliverable

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Third Party, Contract

Depends on Experience

Empower CDS administration

Greenfield, Indiana

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23d ago

Job Title: Empower CDS administration/ support Location: Greenfield, IN(Relocation is fine) Duration: Long term contractEducational Qualification*Any Bachelor's DegreeExperience Range8-12 yearsPrimary (Must have skills)* - To be Screened by TA Team3+ years of hands-on experience in Empower CDS administration and support. 3+ years of experience on HPLC/UPLC and other analytical instrument integration. 3+ years of experience on Computer System Validation (CSV) and preparation of validation deliv

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Full-time

$80,000 - $100,000

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

Remote

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Today

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

MES Functional Consultant - Rockwell

Indianapolis, Indiana

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Today

Role Name : MES Functional Consultant Location : Indianapolis, IN(Onsite) Contract - Onsite Job Summary: We are seeking an experienced MES Functional Consultant with expertise in Rockwell PharmaSuite to support the design, configuration, and deployment of Manufacturing Execution Systems within pharmaceutical operations. Key Responsibilities: Participate in Fit-Gap Analysis to identify business requirements and process gaps.Collaborate with Area Leads and Process SMEs for process modeling and

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Contract, Third Party

Depends on Experience

Project Manager Regulated Systems (Veeva Implementation)

Remote

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Today

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

•

Today

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

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

Clinical Domain SME || NC

Remote or Hybrid in Cary, North Carolina

•

Yesterday

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

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Today

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

Senior Staff Software Advance Quality Engineer (REMOTE)

Remote or Portage, Michigan

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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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4d 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

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21 CFR Part 11 jobs in Indiana, USA