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Utilities Qualification(Validation) Engineer

Salt Lake City, Utah

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Today

Job Description: A pharmaceutical/biotech client in Utah is seeking a mid-to-senior level Utilities Qualification Engineer with 5+ years of experience in critical utilities validation and qualification. The candidate will support GMP manufacturing operations by qualifying and documenting systems like AHUs, purified water, compressed air, and legacy cleanroom systems. This is a fully onsite role and requires a self-driven individual with hands-on experience in IQ/OQ/PQ, EDMS tools (Glorya

Full-time

Lead Engineer

Sandy, Utah

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Today

Job Description: Onsite Engineer plans, leads, reviews and front-ends Design Verification, Sustaining Engineering and New Product Development projects as a technical contributor cum project leader and engages in all aspects of product development. Responsibilities: Leads the Design Verification, Sustaining Engineering & New Product Development projects and applies the best engineering practices and tools. Demonstrates good project management, contributes on projects as the R&D member, carrying

Full-time

Senior Engineer, Quality

Salt Lake City, Utah

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Today

Job Description The Senior Quality Engineer (Quality Operation) provides hands-on technical quality engineering support and direction in quality assurance and quality control aspects of the SLC operation to facilitate an environment of compliance and meeting business objectives. The position requires good knowledge on the disciplines within a medical device QMS and knowledge and understanding of manufacturing, quality control processes and risk management. The incumbent will focus on verificati

Full-time

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

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

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

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

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

Easy Apply

Contract

Depends on Experience

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

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

Easy Apply

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

Manufacturing Engineer

Salt Lake City, Utah

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Today

Manufacturing Engineer Salt Lake City, UT Job Description: 5+ years of experience & demonstrated proficiency in manufacturing, Process validation & providing ongoing technical support is preferred with evidence of continued self-development. Work experience in the Medical Device industry. Must Have Technical/Functional Skills In-depth knowledge of FDA regulations, Industry standards, and guidelines such as ISO 13485 and ISO 14644. Experience in control facility, warehouse and cleanroom validati

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Full-time

IBM Maximo EAM Specialist

Remote

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2d ago

Position Title: IBM Maximo EAM Specialist Location: 100% Remote (East Coast is preferred,Duration: 6+ Months Job Details:MUST HAVE PAST THERMO FISHER EXPERIENCE! Maximo Experience is not the only key skill sets for the positions. Experience in Pharma/ Bio Tech is a MUST Maximo Life Science Industry Solution ExpertiseFDA regulatory experiencePharma validation, change managed, calibration data sheets for life sciencesSignature reference using FDA guidelinesGMP experienceTFS key application experie

Easy Apply

Contract, Third Party

$65 - $70

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

Easy Apply

Full-time, Contract

BASED ON EXPERIENCE

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