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Hybrid in King of Prussia, Pennsylvania

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14d ago

Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterf

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Third Party, Contract

Depends on Experience

EMS Validation Engineering Lead

Horsham, Pennsylvania

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Today

What will you do? As an EMS Validation Engineering Lead, you will play a lead role in ensuring Schneider Electric's (SE's) Environmental Monitoring System (EMS) deployment meets all industry, regulatory, and customer requirements. This position will be responsible for supporting all aspects of our Life Science projects, from our pre-construction and sales activities, through design and Implementation, to our service and maintenance programs. This position requires a strong blend of project tea

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

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

Remote or Hybrid

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Today

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

Full-time

USD 186,200.00 - 285,300.00 per year

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

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

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

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

Director of Data Engineering

Remote

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20d ago

Position Summary: The Director of Data Engineering will spearhead the end-to-end design, development, and optimization of a new healthcare data infrastructure, ensuring seamless operations, advanced analytics, and robust reporting solutions in a dynamic, high-growth environment. Qualifications: Education, Licensure and Certifications, Related Work Experience Degree in computer science, engineering, or related field.8+ years of experience in data engineering, with at least 3 years in a leaders

Full-time

Systems Engineer III - MBSE

Remote or Lone Tree, Colorado

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Today

The ISR (Intelligence, Surveillance & Reconnaissance), Aviation, and Security (IAS) business area is a leader in ISR and aviation, it is a leading prime manned and unmanned aircraft systems integrator for innovative, high-performance ISR and aviation systems. Its end-to-end Command, Control, Computers, Communications and Intelligence, Surveillance & Reconnaissance (C4ISR) capabilities encompass design, integration, test, certification, ground/flight training and complete logistics support. IAS t

Full-time

USD 108,496.89 - 149,183.22 per year

Systems Engineer II - MBSE

Remote or Lone Tree, Colorado

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Today

Full-time

USD 94,345.12 - 129,724.54 per year

Sr Systems Engineer - MBSE

Remote or Lone Tree, Colorado

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Today

Full-time

USD 143,487.14 - 197,294.82 per year

Quality Control Investigations Specialist

Lansdale, Pennsylvania

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29d ago

Piper Companies is seeking an Quality Control Investigations Specialist to join a global leader in vaccine and pharmaceutical manufacturing in Lansdale, PA. Responsibilities of the Investigations Specialist: Conduct detailed trend analysis for a variety of virology-based assays Generate and maintain accurate documentation to record results and assess potential changes Support process improvement initiatives, including the standardization and execution of test methods and assay validation/quali

Full-time

Engineer III, Validation

Remote or Fair Lawn, New Jersey

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the

Full-time

Mid/Senior Cyber Systems & Acquisition Analyst

Remote or Washington

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Today

Overview SimVentions is seeking a Cyber Systems Analyst/Engineer to support the SPEIR and LEED programs within PEO IWS 2.0 Above Water Sensors. This role provides direct support to APMs, Lead System Engineers, and Task Leads. A hybrid work environment is available, but on-site work in the DC area is required 2-3 times per week, with occasional travel (up to 10%). Travel Travel to Washington D.C. area 2-3 times per week and additional travel up to 10% of the time (1-2 times/month). Clearance

Full-time

USD 100,000.00 - 175,000.00 per year

(USA) Staff, Data Engineer

Remote or Bentonville, Arkansas

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Today

Position Summary What you'll do Come join our People Data Engineering Team @Walmart where you'll have the opportunity to manage people data at Walmart scale and make sure the consistent data is being utilized across transactional and analytical systems. About Team: The Enterprise People Technology team supports the successful deployment and adoption of new People technology across the enterprise. As a Fortune #1 company, our work impacts millions of associates globally. We strive to continuou

Full-time

USD 110,000.00 - 220,000.00 per year

Sr Systems Engineer (Hybrid Eligible)

Remote or Lone Tree, Colorado

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Today

Full-time

USD 143,487.14 - 197,294.82 per year

Senior Data Architect/Engineer - C13 - JERSEY CITY

Remote or Jersey City, New Jersey

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Today

About Citi Citi, the leading global financial services company, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Citi provides consumers, corporations, governments and institutions with a broad range of financial products and services, including consumer banking and credit, corporate and investment banking, securities brokerage, transaction services, and wealth management. Our core activities are safeguarding assets, lending money,

Full-time

USD 142,320.00 - 213,480.00 per year

Sr Systems Engineer - Requirements Lead (Hybrid Eligible)

Remote or Lone Tree, Colorado

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Today

Full-time

USD 143,487.14 - 197,294.82 per year

Systems Engineer II

Remote or Vandalia, Ohio

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Today

Full-time

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