Validation Analyst Jobs in Great Valley, PA

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Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

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 5 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 39 days ago | Updated moments ago

Validation Lead

TechDigital Corporation

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King of Prussia, Pennsylvania, USA

Third Party, Contract

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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Posted 11 days ago

EMS Validation Engineering Lead

Schneider Electric

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Horsham, Pennsylvania, USA

Full-time

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
Posted 17 hours ago | Updated 5 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 5 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 3 days ago | Updated 5 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 5 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 47 days ago | Updated 5 hours ago

Mid/Senior Level Validation Specialist/Engineer

Katalyst Healthcares and Lifesciences

•

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 51 days ago | Updated 5 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 60+ days ago | Updated 5 hours ago

Engineer III, Validation

Thermo Fisher Scientific

•

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 13 days ago | Updated 5 hours ago

Engineer II, Validation

Thermo Fisher Scientific

•

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 19 days ago | Updated 5 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