GAMP Jobs in Indiana

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Computer System Validation Lead

Nityo Infotech Corporation

Remote

Contract, Third Party

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

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

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

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

Lead IT Validation Consultant

Amaze Systems Inc

New York, USA

Contract, Third Party

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used

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

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.

Automation Controls Engineer (2ndShift)

Bytecubit Technologies

Indianapolis, Indiana, USA

Contract

Job Title: Automation Controls Engineer (2nd Shift)Location: Indianapolis, INDuration: 6 monthsPay Rate: $45/hr-$55/hr (depending on experience) Job Description: This role will be responsible for supporting the design, installation, and validation for the sterile purification and recycling isolators into commercial production. Bachelor s degree in engineering, Computer Science, Automation, or related field with 7+ years of relevant engineering experience in the Pharmaceutical or Chemical indust

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

Engineer II, Validation

Thermo Fisher Scientific

Remote or St. Louis, Missouri, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you

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

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

Investment consultant

Vy Systems

Remote

Full-time

1. Fund Accountant Alternate Asset Management Job Description: We are seeking a detail-oriented Fund Accountant with experience in Alternate Asset Management to join our finance team. The role requires strong knowledge of NAV calculations, portfolio accounting, and partnership structures. Responsibilities: - Perform daily, weekly, and monthly fund accounting for hedge funds, private equity, and other alternative investment vehicles. - Calculate NAVs, process capital activity (subscriptions/redem

Lead Instructional Designer

Precision System Design Inc.

Remote

Contract

Our direct, F100 client is looking for a lead-level Instructional Designer to lead the development of high visibility learning solutions. This role requires hands-on experience with both Articulate and Lectora tools, along with a strong foundation in instructional design principles.You'll be responsible for analyzing learner needs, designing and developing engaging course materials, and supporting performance improvement initiatives across a variety of learning formats (eLearning, instructor-led

Process Development Engineer - Early Phase Peptide/Oligonucleotide

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