- Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
- You should have excellent understanding of CFR Part , ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
- Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
- Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements
- Reports which summarize the results of the protocol executions
- Exception reports which identify defects or issues during test execution Review vendor documentation
- Requirement Specification document review and approvals
- System Implementation Plan Review
- System Implementation Summary Report Review
- Review and Pre-Approve ST/UAT Test Scripts in ALM
- Create, Update RRA (Regulatory Risk Assessment) and obtain approvals
- Post Execution Review and Post Approvals in ALM
- gR Implementation Approvals
- Retirement Plan Revew Requirements:
- Requirement document
- Validation/Test Plan
- Requirement Traceability Matrix
- Change Requests
- Impact assessment document
- Test/Validation Summary Report
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Validation Engineer
20 hours ago
Katalyst Healthcares and Life Sciences Jersey City, United StatesResponsibilities: Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and client's corporate principles, quality policies, standards, and core va ...
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Validation Engineer
3 days ago
Cynet Systems Jersey City, United StatesJob Description: · Pay Range $50hr - $55hr Support cross functional teams in processing documents (assist in document editing, review, approvals). · ssist in process improvements for Document Control Management/Training processes. · Revise SOPs related to Document Control/Train ...
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Validation Engineer
6 hours ago
Katalyst HealthCares & Life Sciences Jersey City, United StatesResponsibilities · : · Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. · You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA a ...
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Validation Engineer
5 days ago
HCLTech New York, United StatesJob Description : · 1) 7 to 9 years of Experience in Software verification and testing activities. · 2) Design, develop, and execute comprehensive test plans, test protocols and test cases for verification and validation of embedded software. · 3) Collaborate with cross-function ...
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Validation Engineer
6 hours ago
SPECTRAFORCE New York, United StatesJob Title: Validation Engineer I/ II · Duration: 07 Months · Location: Athens, GA 30601 · Pay Range: $45- $48/hr on W2 · Roles and responsibilities: · Perform Smoke studies and assist in semi annual Media fill qualifications as a SME · Perform requalification/periodic review of ...
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Validation Engineer
1 day ago
Katalyst Healthcares and Life Sciences New York, United StatesResponsibilities:Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams. · Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packagi ...
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Validation Engineer
3 weeks ago
LS Solutions Inc. New Jersey, United States Full time, contract, trainingKey Responsibilities Strong Experience in Computer Systems Validation (CSV) within the pharmaceutical industry. Required Bachelor's degree in pharmaceutical Science OR related field of study. Schedule and plan equipment and process qualification workload to meet approved schedule ...
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Clean Validation Engineer
2 days ago
Trinity Consultants New York, United StatesADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufac ...
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HiL Validation Engineers
4 days ago
Akkodis New York, United StatesAkkodis is seeking two experienced HiL Validation Engineers for full-time roles in the Detroit Metropolitan area. Qualified candidates will possess more than three years of professional experience in hardware-in-loop testing (bench) accompanied by Python and/or CAPL scripting for ...
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Senior Validation Engineer
5 days ago
BioPhase New York, United States*US Citizens or Greencard Holders only* · **No C2C** · Work Schedule: · Onsite - M-F · Salary: · $60-70/hr · Duration: · 4 months · Primary Responsibilities: · Support the Quality Engineering group with documentation and validation needs. · Draft URS documents, design specif ...
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Senior Validation Engineer
5 days ago
SciPro Inc. New York, United StatesSenior Validation Engineer (Contract) · Location: · Van Nuys Area · Role Overview · We're seeking a highly skilled Senior Validation Engineer for a temporary onsite role. Reporting to the Manager of Quality Engineering, you'll support our quality engineering team with documenta ...
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CSV Validation Engineer
5 days ago
Hire IT People New York, United StatesResponsibilities: · Draft and implement Quality System documentation designed to establish good validation practices within the organization. · Author URS, FRS, Risk Assessments, Configuration specification, design specification and CSV test protocols and execute them in complian ...
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Junior Validation Engineer
14 hours ago
ALTEN Technology USA New York, United StatesWe're ALTEN Technology USA , an engineering company that provides solutions for engineering, technology, and product development projects. For decades, we've been helping our clients develop products that are changing the world, whether that's by shaping the future of space explo ...
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Senior Validation Engineer
5 days ago
RBW Consulting New Jersey, United States Full timeSenior Validation Engineer · Are you a validation expert looking for a new, dynamic environment? · I am partnering with a rapidly growing full service CDMO who are specialised within sterile product development, manufacturing and packaging, and am working with the leadership tea ...
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Senior Validation Engineer
1 day ago
CAI New York, United StatesPosition Description: · The CQV Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible for protocol writing and execution (field verification), and development of s ...
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Modem system validation Engineer
20 hours ago
Evolutyz Corp Jersey City, United StatesModem system validation engineer (2 positions) · Bedminster, NJ- 2- position · 12 Months · Onsite/Hybrid · Find the JD below for your quick reference. Looking for someone with strong 5G protocol and Log Analysis skills.Conduct research and analysis to define features and func ...
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Engineer (m/w/d) System & Product Validation
5 days ago
ROSA AG New York, United StatesJob-ID: · 10929 · Einsatzbeginn: · Einsatzort: · München · Land: · Deutschland · Einsatztyp: · Büro · Vertrag: · Festanstellung · Beschreibung · Sie prüfen und beurteilen Versuchsanfragen hinsichtlich Kosten und Machbarkeit · Sie sind für die Erstellung von Validierungsplä ...
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Computer System Validation Engineer
2 days ago
HCLTech New York, United StatesHCLTech is a global technology company, home to 211,000+ people across 52 countries, delivering industry-leading capabilities centered around digital, engineering and cloud, powered by a broad portfolio of technology services and products. We work with clients across all major ve ...
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Hardware/Electrical Validation Engineer
5 days ago
The Select Group New York, United StatesJoin Our Team as a Validation Engineer · Are you ready to make a significant impact in the cloud networking industry? Our client, a premier cloud networking company, is seeking a talented Validation Engineer to join their Electrical Design Validation Testing (EDVT) team. As a Val ...
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HVAC Controls Validation Engineer
2 days ago
Capgemini Engineering New York, United StatesJob Tittle - HVAC Controls Validation Engineer · Location - Auburn Hills, MI (onsite) · Job Description : · Capgemini Engineering is seeking a skilled HVAC Controls System Validation and Root Cause Engineer. This role will be pivotal in supervising the software validation proces ...