principal validation engineer Jobs in indiana

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Principal Engineer, Validation

Novo Nordisk Inc

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Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product f
Posted 60+ days ago | Updated 4 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 23 days ago | Updated 4 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 60+ days ago | Updated 4 hours ago

Electrical Validation Engineer

Steck Systems

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Remote

Contract, Third Party

Job: Senior Electrical/Systems Test Engineer What the job involves We are seeking an Electrical/Systems Test Engineer to join our team. In this role, you will play a critical part in the testing and validation of our hardware systems. You will work on Electrical/system testing, validation, and hardware debugging of electrical components and systems involving edge processors, cameras and Linux environment. Responsibilities You will be responsible for system-level testing & debugging, and hardware
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Posted 8 days ago | Updated 2 days ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

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
Posted 13 days ago | Updated 4 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 33 days ago | Updated 4 hours ago

Validation Engineer

Apex Systems

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Lebanon, Indiana, USA

Full-time

Job#: 2078205 Job Description: Role: Equipment Validation Engineer Location: Indianapolis, IN (On-Site) Type: Long Term Contract Apex Systems, a global leader in Technology Services, is searching for an Equipment Validation Engineer in Indianapolis, IN for a large Life Sciences client. This is a long term contract with an immediate start date. This role requires on site support 5 days a week due to the nature of the role. See below for more details! Duties and Responsibilities: Supports the
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Posted 50 days ago | Updated 4 hours ago

Engineer III, Test & Validation

Landis Gyr

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Lafayette, Indiana, USA

Full-time

At Landis+Gyr, we don't just manage energy-we lead the transformation toward a smarter and more sustainable energy future. With a net revenue of USD 1.73 billion in FY 2024, and a presence in over 30 countries across five continents, Landis+Gyr empowers utilities and consumers to optimize energy usage through advanced metering, grid-edge intelligence, and powerful data analytics. Today, our global team of about 6,300 professionals is shaping the digital energy era-developing innovative technol
Posted 49 days ago | Updated 4 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Warsaw, Indiana, USA

Full-time

Responsibilities: Develops and Executes Cleaning Validation Strategies: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective cleaning processes for medical devices and equipment. Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends
Posted 60+ days ago | Updated 4 hours ago

Equipment Validation Engineer

Apex Systems

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Indianapolis, Indiana, USA

Full-time

Job#: 2073087 Job Description: Role: Equipment Validation Engineer Location: Indianapolis, IN (On-Site) Type: Long Term Contract Apex Systems, a global leader in Technology Services, is searching for an Equipment Validation Engineer in Indianapolis, IN for a large Life Sciences client. This is a long term contract with an immediate start date. This role requires on site support 5 days a week due to the nature of the role. See below for more details! Duties and Responsibilities: Supports the
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Posted 60+ days ago | Updated 4 hours ago

Validation Lead, SAP S4 HANA

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati
Posted 60+ days ago | Updated 4 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 4 hours ago

Sr. Analyst, IT Validation Services

Russell, Tobin & Associates

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Remote or Stamford, Connecticut, USA

Contract

Job Title: Sr. Analyst, IT Validation Services Location: Remote Duration: 12 Months Pay Range: $30/hr-$35/hr on W2 (DOE) Primary Responsibilities Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls: Validation Plans/Summary Reports Risk Assessments User Requirements Specifications Test Plans Test Scripts: IQ, OQ or PQ Assess and implement the most effective validation strategy for each activity. Oversee test execution for c
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Posted 59 days ago | Updated moments ago

Technical Lead - Validation, Tools, and Acceleration (VTA)

General Motors

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Remote

Full-time

Job Description Remote: This role is based remotely but if you live within a 50-mile radius of [Atlanta, Austin, Detroit, Warren, Milford or Mountain View ], you are expected to report to that location three times a week, at minimum. Role Overview: As a Technical Lead within the Validation, Tools, Acceleration (VTA) team under the Simulation, Evaluation, and Data organization, you will be a senior individual contributor building and optimizing the infrastructure and required technology for all
Posted 51 days ago | Updated moments ago

REMOTE - RT SCADA to EMS ? GE EMS Expert / EMS Validation Specialist

Metasys Technologies

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Remote

Contract

RT SCADA to EMS - GE EMS Expert / EMS Validation Specialist Remote 12+Month ContractThis role will support the deployment, integration, and validation of SCADA/EMS systems to ensure secure, stable, and efficient grid operations. Candidates must have deep experience with GE EMS platforms, real-time data integration, and EMS validation processes. Responsibilities Support deployment, integration, and validation of SCADA/EMS systems Configure and validate real-time data exchange using protocols (DNP