validation analyst Jobs in ambler, pa

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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 48 days ago | Updated 2 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 27 days ago | Updated moments ago

Validation Lead

Cynet Systems

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King of Prussia, Pennsylvania, USA

Contract

Job Description: Pay Range: $50hr - $55hr 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 Waterfall methodology-based software development Compliance and h
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Posted 3 hours ago | Updated moments ago

MHE Commissioning & Validation Project Manager - Remote

VIVA USA INC

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Remote

Contract

Title: MHE Commissioning & Validation Project Manager - Remote Mandatory skills: warehouse automation, MHE, industrial systems, commissioning, validation, automated systems, warehouse operations, performance metrics, project coordination, testing protocols, compliance standards, safety regulations, IT, systems, controls issues, non-compliance, facilitate mitigation, test plans, MHE systems, hardware commissioning, validation activities, Functional testing, performance validation, Installation q
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Posted 7 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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Lawrence Township, New Jersey, USA

Full-time

Roles & Responsibilities: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in
Posted 48 days ago | Updated 2 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 48 days ago | Updated 2 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 48 days ago | Updated 2 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Fair Lawn, New Jersey, USA

Full-time

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
Posted 35 days ago | Updated 2 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Philadelphia, Pennsylvania, USA

Full-time

Job Summary The Validation Engineer is responsible for executing equipment and system validation activities within a regulated biopharmaceutical environment. This role involves implementing validation protocols, documenting results, and ensuring compliance with regulatory requirements. The position is based in West Philadelphia, Pennsylvania with a hybrid work arrangement. Responsibilities: Proficiency in Kaye AVS validation software. Experience with Valpro validation management systems. Compet
Posted 48 days ago | Updated 2 hours ago

Lab Equipment Validation Engineer

Katalyst Healthcares and Lifesciences

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Philadelphia, Pennsylvania, USA

Full-time

Responsibilities: Our client is looking for a lab equipment validation engineer to come on-site for a 6 months project. This work will be fully on-site in PA. They are moving buildings, so all of the Laboratory equipment will be decommissioned and then put in the new building. They need this Consultant to come in and requalify, revalidate, and commission the Laboratory Equipment. They will also be getting some new Laboratory Equipment in as well - HPLC, Cell Counters.Requirements: This Consultan
Posted 48 days ago | Updated 2 hours ago

Analytical Validation Engineer

Zachary Piper Solutions, LLC

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Hopewell Township, New Jersey, USA

Full-time

Piper Companies is looking for an Analytical Validation Engineer to support commissioning and decommissioning activities for a major pharmaceutical company in the Titusville, NJ area. Responsibilities for the Analytical Validation Engineer include: Experience in Pharmaceutical Laboratory Operations Must be familiar and have experience with laboratory instrument selection, installation (IQ/OQ) and qualification (PQ) Experience supporting laboratory investigations from beginning to end, includ
Posted 15 days ago | Updated 14 days ago

Mid/Senior Level Validation Specialist/Engineer

Katalyst Healthcares and Lifesciences

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Pennsylvania, USA

Full-time

Roles & Responsibilities: Minimum of Four (4) years of experience with commissioning and qualification including using ISPE C&Q guidelines. Knowledge of Kneat e validation software preferred. Prior experience with analytical instrumentation qualification and controlled temperature unit qualification is required. Strong technical writing skills, verbal and written communication skills. Strong interpersonal skills (requires interaction with client employees). Responsible for the development an
Posted 39 days ago | Updated 2 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 1 day ago | Updated 2 hours ago

Engineer II, Validation

Thermo Fisher Scientific

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Remote or St. Louis, Missouri, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you
Posted 7 days ago | Updated 2 hours 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 18 days ago | Updated 11 hours ago

RTL Validation Engineer

Millennium Global Technologies

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Remote

Contract, Third Party

Position: RTL Validation Engineer Location: Dallas, TX ( Remote) Duration: 6 months Visa Preference: GC s, EAD s, L2 EAD s RTL Validation, working knowledge of PCIE/CXL protocols. Familiarity with simulation technologies.Exceptional analytical skills and problem solving skills.Experience in crafting testbenches, methodologies for large and complex chips.Deep understanding of verification concepts.Proficiency with at least one of these - C++, Object Oriented Programming, UVM, System Verilog.Fam