OQ jobs in Indianapolis, IN

Indianapolis, Indiana

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Today

The Science Team at Russell Tobin & Associates supporting the Pharmaceutical Industry that has an opening for Process Development Engineer in Indianapolis, IN! Position Summary: The Process Development Engineer plays a vital role in maintaining, troubleshooting, and optimizing equipment reliability in a regulated pharmaceutical manufacturing environment. Responsibilities include performing preventive, predictive, and corrective maintenance on mechanical, pneumatic, hydraulic, and control systems

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Full-time, Contract

BASED ON EXPERIENCE

Senior / Principal Process Engineer - APIEM

Indianapolis, Indiana

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Today

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Full-time

USD 66,000.00 per year

Area Engineer - Small Molecule Building Lilly Medicine Foundry

Lebanon, Indiana

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Today

Full-time

USD 66,000.00 per year

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

Computer System Validation Engineer 1

Remote

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Today

Title: CSV Engineer 1 Location: Remote About: The CSV Engineer 1 will support Computer System Validation (CSV) activities for GxP-regulated systems. This role involves executing validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and company quality standards. The candidate will work closely with IT, Quality, and Business teams to maintain a validated state of systems. Key Responsibilities Assist in the development and execution of validation documentation, inclu

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Contract

SAP PPQM PTS Consultant Remote

Remote or Atlanta, Georgia

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Today

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, Third Party, Contract

Associate Director - Engineering API External Manufacturing Peptides & Large Molecules

Indianapolis, Indiana

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Today

Full-time

USD 118,500.00 - 173,800.00 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

Senior Supplier Engineer

Remote or Danvers, Massachusetts

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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 91,000.00 - 147,200.00 per year

Validation Engineer III

Remote or Durham, North Carolina

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Today

Job Description Summary The Validation Engineer , is responsible for authoring, executing and reviewing/approval of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsi

Full-time

USD 89,600.00 - 166,400.00 per year

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

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

Veeva Migration Consultant

Remote

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26d ago

We have a below position for Veeva Migration expert for remote work, please find the JD below and let me know your interest. Title: Veeva Migration Consultant Exp: 7+ to 10 years of experience in Veeva migration and implementation activities Duration: 6-12 Months Responsibilities: Migration Work stream Lead-Veeva RIMS Implementation Key Responsibilities Migration Strategy & PlanningDefine migration scope, timelines, resources, and success metrics.Develop detailed migration plans and risk mitiga

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Contract, Third Party

Depends on Experience

LabVantage LIMS Configurator

Remote

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Today

RAYVEN IT Solutions is a leading IT Consulting firm offers a comprehensive range of services that are domain specific with a strong focus on technology, business process & practices. Founded by top-notch profs with the vision of bridging the gap between people, process & technology. RAYVEN has the capability & resources to help clients realize their technology driven business transformation initiatives. We are specialized & provide solution-based services to our clients in the areas of SAP/ERP.

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Third Party, Contract

Depends on Experience

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor 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 degree

Full-time

LIMS and QC Applications Consultant

Remote or Hybrid in Bridgewater, New Jersey

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Today

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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Full-time, Contract

BASED ON EXPERIENCE

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OQ jobs in Indianapolis, IN, USA