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Computer System Validation (CSV) Engineer

Muskegon, Michigan

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Today

Job Title: Computer System Validation (CSV) Engineer Location: Muskegon, MI (Onsite) Job Type: Contract Responsibilities: The Validation Specialist carries out quality control checks on engineering project work under the supervision of the Validation Lead, Automation Lead and Project Manager. Perform initial CSV at client site for systems including DeltaV, Historian, MES, ABB as well as other DCS and OT systems. They will review and approve risk assessment link to CSV of systems. Collaborate wit

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Full-time, Part-time, Contract, Third Party

$Negotiable

Sr. CSV Engineer

Muskegon, Michigan

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17d ago

Job Title: Sr. CSV Engineer Location: Muskegon, MI (Onsite- 5 days a week) Experience: 11+ years Must Have's: Validation of OT Systems such as DeltaV, manufacturing floor familiarity, life science background. JD from HM: The Validation Specialist carries out quality control checks on engineering project work under the supervision of the Validation Lead, Automation Lead and Project Manager.Perform initial CSV at client site for systems including DeltaV, Historian, MES, ABB as well as other DCS an

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Contract, Third Party

Depends on Experience

compliance lead

Remote

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Yesterday

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc

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Contract

Depends on Experience

Supplier Project Engineer

Remote

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2d ago

Education and Experience: 3 years of relevant experienceBS Engineering Degree (Plastics, Mechanical, Manufacturing/Industrial) or related fieldPreferred Skills and Competencies: Ability to manage Supply Chain projects concept to production, including the authoring and oversight of IQ/OQ/PQ protocols for component manufacturing processes and secondary Job Description Summary operations: Strong written and verbal communication skills Possess strong analytical and problem-solving skills Familiari

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Contract

Depends on Experience

Sr. Engineer, Packaging

Remote or El Paso, Texas

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Today

What Packaging Engineering contributes to Cardinal Health Packaging Engineering is responsible for designing, developing and testing a wide variety of equipment and packaging used for protection, display and handling of products. Determines packaging specifications, cost limitations, legal requirements, and related documentation. Directs external resources / contractors as required. The ideal candidate would be located in the El Paso, Texas area and this position is a hybrid role. Responsibilit

Full-time

USD 67,500.00 - 96,400.00 per year

Senior Commissioning, Qualification & Validation (CQV) Engineer

Remote or Athens, Georgia

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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

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. 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

Full-time

Sr. Validation Engineer (CSV)

Muskegon, Michigan

•

Today

Roles & Responsibilities: The Validation Specialist carries out quality control checks on engineering project work under the supervision of the Validation Lead, Automation Lead and Project Manager. Perform initial CSV at client site for systems including DeltaV, Historian, MES, ABB as well as other DCS and OT systems. They will review and approve risk assessment link to CSV of systems. Collaborate with the other departments, within their respective areas of responsibility for Change Managemen

Full-time

Computer System Validation Engineer

Remote or New Jersey

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Today

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

Full-time

Validation Lead, SAP S4 HANA

Remote or New Jersey

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Today

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

Full-time

Manager, IT/Senior Systems Analyst

Remote or Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Manager, IT/Senior Systems Analyst HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Support Thermo Fisher's integration of Tracelink (Track and Trace Solution) and Thermo Fisher's downstream partners to ensure Thermo Fisher is compliant with Serialization and Track and Trace requirements and detailing the technical

Full-time

Computer System Validation Analyst - R Studio & Clinical Systems

Remote or New Jersey

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Today

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

Full-time

Sr. Analyst, IT Validation Services

Remote or Hybrid in Stamford, Connecticut

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Today

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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Contract

BASED ON EXPERIENCE

Supplier Engineer II

Remote or Danvers, Massachusetts

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Today

Full-time

USD 91,800.00 - 124,200.00 per year

Senior Engineering Manager, Scientific Injection Molding Development and Training

Remote

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Today

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processe

Full-time

USD 135,700.00 - 244,300.00 per year

Senior Engineer, Design Transfer Specialist

Remote or Cambridge, Massachusetts

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Today

Career Category Operations Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each

Full-time

USD 119,195.00 per year

Sr. CSV Engineer

Muskegon, Michigan

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Today

Join a Global Leader in Workforce Solutions - Net2Source Inc. Who We Are: Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 32 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision Right Talent. Right Time. Right Place. Right Price. Position: Sr. CSV Engineer Location: Muskegon, MI - onsite, 5 days a week

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Contract

$55 - $60 hr

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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