gamp Jobs in indiana

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Engineer - Syncade or PharmaSuite MES System

Lilly

Indianapolis, Indiana, USA

Full-time

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

Engineer - Syncade or PharmaSuite MES System

Lilly

Indianapolis, Indiana, USA

Full-time

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

Computer System Validation Lead

Nityo Infotech Corporation

Remote

Third Party, Contract

Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA Gu

Engineer - Syncade or PharmaSuite MES System

Eli Lilly and Company

Indianapolis, Indiana, USA

Full-time

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

Engineer - MES System

Eli Lilly and Company

Indianapolis, Indiana, USA

Full-time

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

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

Remote or Massachusetts, USA

Full-time

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

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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

SAP Finance FICO Consultant

URSI Technologies Inc.

Remote

Contract

SAP Finance FICO Consultant San Francisco, CA Remote Remote Qualifications The ideal candidate will have hands-on experience in SAP S4HANA and ECC, a strong understanding of GAMP 5, cGMP, and SOX compliance requirements, and proven application support skillsKey Responsibilities: Provide application support for SAP FICO modules within a regulated IT environmentTranslate business requirements into SAP solutions using SAP Best Practices, FIORI apps, and embedded analyticsJob description : 9+ to 15

Payroll Accounting Consultant

Grepforce LLC

Remote

Contract

What we look for: Bachelor's degree in Accounting, Finance, or related field.5+ years of general ledger and payroll accounting experience.Strong understanding of GAAP and payroll accounting practices.Proficiency in Excel and experience with ERP systems (e.g., NetSuite, Workday, SAP).Strong attention to detail and analytical skills.Excellent organizational and communication skills.Proven ability to work independently and meet deadlines in a dynamic environment.CPA preferredExperience in a high-gr

FSQA - Food Safety and Quality Assurance Manager

Agile Global Solutions, Inc

Indianapolis, Indiana, USA

Full-time

Description: FreshRealm is currently in a high-growth state, and our culture of ACTIONS drives our team members forward to maximize their potential. We are a team of hardworking, passionate leaders who persevere through challenges, collaborate with one another to problem solve and achieve desired outcomes, and work to bring out the best in our employees as we service our customers. At FreshRealm, we welcome individuals from all backgrounds and abilities to apply and make employment decisions bas

Raw Materials Technical Specialist

Aditi Consulting

Remote or Cambridge, Massachusetts, USA

Contract

Payrate: $38.00 - $40.00/hr. Summary: The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing t

Tagetik Technical Support

OnwardPath Technology Solutions LLC

Remote

Contract

Finance/Accounting Degree preferred, and/or at least 10 years in accounting (focus in Financial Closing and Consolidation required; exposure to Foreign Currency is preferred)Deep understanding of the Tagetik architecture and modules (Financial Close, Budgeting & Planning, IFRS/GAAP Consolidation, Financial Reporting).Experience in configuring and customizing Tagetik solutionsExperience with SDLC (System Design Life Cycle) and deployment in Tagetik projects

Process Engineer

Katalyst Healthcares and Lifesciences

Remote or New York, USA

Full-time

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.

Senior Project Engineer(Onsite) Location:Lebanon, Indiana

Stellent IT LLC

Lebanon, Indiana, USA

Third Party, Contract

Senior Project Engineer(Onsite) Location:Lebanon, Indiana Interview:Phone+Skype Job Description: Need someone to help generate equivalency assessment GAP assesment Talk to every stakeholder of client projects, every single drawing, every system User requirement, software, Hotware, come up with equivalency assessment. Provide recommendations to leverage testing from systems on site. Technically inclined individual and worked with many groups of people Tasks: tremendous impact on the project

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Tax Manager

Toyota Material Handling

Columbus, Indiana, USA

Full-time

Job Description POSITION: Business Card Title: Tax Manager Internal Job Level: Assistant Manager Department: 100004-Tax FLSA Status: Exempt Employment Type: Full-Time Reports To: Senior Tax Manager COMPANY OVERVIEW: Toyota Industries North America, Inc., an American Holding Company and the North American office of Toyota Industries Corporation (TICO) in Japan. The company is headquartered in Columbus, IN. JOB SUMMARY : This Tax Manager role is a key team resource with strong technical kno

Field Service Engineer I (lab equipment)

Thermo Fisher Scientific

Colorado, USA

Full-time

Work Schedule Other Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Field Service Engineer (lab equipment) When you join us at Thermo Fisher Scientific, you'll be part of an inquis

Automation Engineer

Advantage Technical

Jeffersonville, Indiana, USA

Full-time

Automation Engineer Essential Duties and Responsibilities: Process Optimization and Efficiency Lead efforts to improve batch and mechanical efficiencies within packaging and device assemblyprocesses Identify and implement process improvements to reduce cycle times, increase output, and ensure thehighest quality standards Collaborate with production teams to resolve issues related to equipment, process variability, andsystem bottlenecks Drive automation and integration initiatives to enhance th

Finance Analyst ONLY W2

Aziro Technologies LLC

Remote

Contract

SKILLS NEEDED Excellent understanding of US GAAP, revenue recognition, and financial analysis, with advanced knowledge in Profit and LossExcellent analytical skillsExcellent business application skills (e.g., Microsoft Excel). Must be able to make pivot tables, analyse revenue, costs, apply procedures, determine actions to be taken and prepare summary reports.Knowledge of SAP ERP, booking manual Journal Entries, Intercompany Billings is mandatorySuperior communication and influencing skills, sho

Reliability Engineer - Frankfort, IN

Archer Daniels Midland

Frankfort, Indiana, USA

Full-time

Job Description Reliability Engineer - Frankfort, IN Job Description This position will focus on improvements in equipment reliability by analyzing bad actors and equipment issues through failure analysis and zero-loss methodology. The Reliability Engineer will also be responsible for proactively incorporating reliability into the design and commissioning of new equipment. ResponsibilitiesWorks closely with the Maintenance Superintendent, Plant Manager and site leaders to develop, coordinate,