GAMP jobs in Indiana

Lebanon, Indiana

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26d ago

Lead the BMS validation lifecycle across all 8 LMF buildings, from URS authoring through Validation Summary Report and closeout.Author and obtain approval for User Requirement Specifications (URS) for the Metasys BMS platform.Engage JCI on Software Requirement Specifications (SRS) review and acceptance.Develop and execute Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.Risk based approach adhering to Lilly Q

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Depends on Experience

Senior DeltaV Automation Engineer - Only W2

Remote or Muskegon, Michigan

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Today

Role: Senior DeltaV Automation Engineer Location: Muskegon, MI (Onsite) Job Type: Contract (W2) Years of Experience: 12 years required Skill Matrix: Name Required LS Yes Emerson Delta V Yes Role requires a senior level automation engineer comfortable operating independently while supporting others. No CSV authorship responsibility: CSV activities are supported indirectly through automation execution and issue resolution. DeltaV DCS automation experience in pharmaceutical / biopharma manufacturi

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Lab IT Systems Lead - Validation & Data Integrity

Lebanon, 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 64,500.00 - 151,800.00 per year

Manager - Validation Lead - Technical Support & Operations - Global Services

Indianapolis, Indiana

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Today

Full-time

USD 64,500.00 - 151,800.00 per year

CSV Engineer

Indiana

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Today

Job Summary: The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant with regulatory standards, including 21 CFR Part 11. The role requires strong expertise in GAMP 5 methodology, validation lifecycle processes, and experience with automation and control systems. This is an onsite position based in Bloomfield, Indiana. Roles & Responsibilities: Execute and manage com

Full-time

CSV Engineer- Automation

Lebanon, Indiana

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25d ago

Lead validation lifecycle activities for automation and control systems at LMF, including DeltaV, PI Historian, Rockwell PLC/HMI, and Metasys platforms.Develop and execute validation plans (VP), user requirement specifications (URS), functional specifications (FS), design specifications (DS), and configuration specifications (CS) for automation systems.Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.Generate and mai

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Depends on Experience

SAP DRC Analyst

Remote

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Today

Position is 100% Remote. Please note I have direct access to the Hiring VP of SAP on this position. Compensation: Base Salary + Bonus: 10% This is an outstanding opportunity for a Sr. SAP DRC Functional Analyst to participate in a large global greenfield SAP S/4HANA implementation. We are the leading Global Biotech Company in our niche and are looking for a Sr. SAP Functional Analyst that has experience with the greenfield implementation or brownfield migration of SAP DRC. We have been in busine

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Full-time

$140,000 - $155,000

Sr. Computerized System Validation (CSV) Manager

Remote

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2d ago

We are Looking for a Senior Computerized System Validation (CSV) Manager with CRO industry experience. This a full-time permanent hire position with our client. In this role you can work fully remote (anywhere in USA). In this role as a Senior Computerized System Validation (CSV) Manager, you will lead the transformation of CSV practices within the organization. In this role as a Senior Computerized System Validation (CSV) Manager you will ensure validation processes are risk-based, efficient, a

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Full-time

Depends on Experience

Cost Accountant Federal Grants

Remote

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25d ago

JobTitle:Cost Accountant Federal GrantsLocation:Washington D.C (Remote)OverviewThe Cost Accountant ensures the integrity of federal grant expenditures by evaluating cost allocation methodologies, validating financial data, and ensuring compliance with 2 CFR Part 200 and client requirements. This role supports sound financial stewardship across hospitals, universities, tribal governments, and nonprofits.Key ResponsibilitiesReview and analyze Cost Allocation Plans (CAPs) and Indirect Cost Rate Pr

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Third Party, Contract

Depends on Experience

lamp developer - remote - willing to relocate NM

Remote

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16d ago

Lamp Developer - Remote Santa Fe, NM - 6-12 months Note: willing to relocate to Santa Fe is good A LAMP developer is a backend or full-stack professional who specializes in building dynamic web applications using the classic open-source quartet of Linux, Apache, MySQL, and PHP. These developers are responsible for the entire server-side architecture, from managing the operating system and configuring the web server to designing complex databases and writing the functional logic that powers a s

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Contract

$50 - $55

Controller

Remote

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4d ago

About SEPA The Smart Electric Power Alliance (SEPA) is a nonprofit 501(c)(3) organization dedicated to accelerating the transformation of the electric power system to deliver clean, affordable, and resilient energy for all. Operating at the intersection of technology, policy, and programs, SEPA convenes, educates, and collaborates with a diverse community of utilities, regulators, policymakers, technology providers, and advocates to address the most pressing challenges in the clean energy transi

Full-time

115000 - 120000

Cost Accountant not CPA

Remote

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24d ago

EducationBachelors degree in Accounting, Finance, or related field required.CPA not required.Qualifications & Required ExperienceLeading a team of cost accountants while remaining hands-on in cost allocation, financial analysis, and compliance reviews,35 years of experience in accounting, finance, or grants management.Hands-on experience withdirect and indirect cost allocation.Experience working with or supportinggrant requestsfrom:HospitalsUniversitiesTribal entitiesNon-profit organizationsUnde

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Depends on Experience

Engineering Technician B7 II

Evansville, Indiana

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4d ago

Arthur Lawrence is looking for an Engineering Technician B7 II one of our clients in Evansville, IN. Please find the job description below and send us your updated resume if interested: Must-Have Skills: 5+ years of pharmaceutical industry experience Strong understanding of validation/qualification processes and regulatory compliance requirementsBachelor s degree in Science, Engineering, or a related discipline Nice to Have Skills: 5+ years of validation and qualification experience Familiarity

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Contract

$40+

Senior Design Verification Lead

Lebanon, Indiana

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12d ago

Hello , My name isCharles PowellandI am a staffing Specialist atVoto Consulting LLC. I am reaching out to you on an exciting job opportunity with one of our clients. Job Title : Senior Design Verification Lead Drug Substance Manufacturing (New Site Build) Duration : 2 Year Contract Location : Onsite in Lebanon, IN Interview : 2 Virtual Interviews ( relocation candidates are okay) Preferred Pharma and Site Expansion experience Update : Heavy P&ID experience, work on P&ID design reviews, revi

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Contract

75+

CSV Engineer

Indianapolis, Indiana

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Today

Roles & Responsibilities: Author equipment qualification and validation packages Plan coordination with equipment manufacturer or supplier for preventative maintenance Technical review and execution of qualification/validation protocols Execution of CSV initiatives Apply knowledge of quality principles, GMPs, federal regulations and standard procedures to deliverables Initiate CSV change controls on equipment Experience: Experience Required: 2-4 Years Experience in executing equipment validati

Full-time

Senior OneStream Implementation Consultant (Financial Systems / F&B Industry)

Remote

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2d ago

Job Title:Senior OneStream Implementation Consultant (Financial Systems Food & Beverage) Location:(Contract, Remote EST) Duration: Long term Client: Beverage Industry General Guidelines We are specifically looking for senior resources who possess a stronger background in project implementation and configuration.Ideal candidates should meet the following criteria:Extensive Implementation Experience:Proven track record of successful configuration experience over 6+ years.Project Volume:Completi

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Contract

Depends on Experience

Civil Structural Architectural (CSA) Construction Quality

Lebanon, Indiana

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3d ago

TITLE-Civil Structural Architectural (CSA) Construction Quality Location- Lebanon, IN 100% on site Duration- 2 YEAR CONTRACT Interview - 2 Virtual interviews 20+ years pharma and industrial Core and shell quality for CSA and fit out Able to diagnose issues and provide resolution Job description Role Overview The Construction CSA Quality Specialist supports quality oversight for pharmaceutical and industrial construction projects, with a focus on core & shell and interior fitout phases. This

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Third Party, Contract

70 - 80

Senior Design Verification Lead

Hybrid in Lebanon, Indiana

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10d ago

Job Title: Senior Design Verification Lead Drug Substance Manufacturing Location: Lebanon, IN Experience: 10+ Years Mode of interview: 2 Virtual Interviews (relocation candidates are okay) Preferred Pharma and Site Expansion experience Update: Heavy P&ID experience, work on P&ID design reviews, review P&IDs line by line. Ability to describe design verification from start to finish. Experience with early design process, detail design experience and specific examples around detail design previ

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Contract

Depends on Experience

Manufacturing Engineer

Indianapolis, Indiana

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Today

Location: Indianapolis, IN Salary: $75.00 USD Hourly - $80.00 USD Hourly Description: Our client is currently seeking a Manufacturing Engineer Job Title : Manufacturing / Utility / Facilities / HVAC Engineer Location : Indianapolis, IN Worksite : Onsite Duration : 12+ months Job Description: This role involves designing, troubleshooting, optimizing, and maintaining critical utility systems to ensure reliability, efficiency, and compliance with industry standards. Required Qualifications Exp

Contract

USD 75.00 - 80.00 per hour

Metrology Specialist

Remote or West Point, Pennsylvania

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Today

Metrology Specialist I On-site in West Point PA Summary: Manage equipment assets at multiple locations Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions Participate in computer system validation activities associated with new or upgraded equipment or software packages. Originate and progress Deviations and Change Control records Perform and document investigations and assist in develo

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GAMP jobs in Indiana, USA