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Validation Specialist
4 weeks ago
Charter Global Philadelphia, United StatesThe Client is one of the top 4 big firms in the USA. · Job Title: Instrument Validation Specialist · Duration: 6 months contract · Notes: · Looking for an Instrument Validation Specialist - need someone familiar with lab equipment, but the overall project will be for both pharmac ...
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Validation Specialist
5 days ago
Catalent Inc Princeton, United States**Position Title:** **Validation Specialist** · M-F 1st shift · **Summary:** · _In this critical position,_ **_the Validation Specialist_** _is responsible for authoring and executing installation, operation and performance process and equipment qualifications (IOPQ)for the si ...
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Computer Systems Validation Specialist
3 weeks ago
LabVantage Trenton, United StatesLabVantage Solutions, Inc. · Computer Systems Validation Specialist · Somerset , · New Jersey · Apply Now · A.Job Description ObjectiveLabVantage Professional Services (PSO) are expanding their team to provide an increased level of Computer Systems Validation (CSV) services ...
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ComforceHealth Trenton, United StatesJob ID: Warren , New Jersey Job Type: Contract Added - 03/18/24Job Description Innova Solutions is immediately hiring a Validation SpecialistJob Title: Validation SpecialistPosition type: Full-time ContractDuration: 12 MonthsLocation: Warren, NJ OnsiteAs a Validation Specialist, ...
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Instrument Validation Specialist
4 weeks ago
Charter Global North Wales, United StatesTitle: Instrument Validation Specialist · Location: West Point, PA · Duration: 6-12+ months contract · Notes: · Looking for an Instrument Validation Specialist - need someone familiar with lab equipment, but the overall project will be for both pharmaceutical equipment validation ...
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Validation Specialist
4 weeks ago
Catalent Inc Princeton, United StatesPosition Title: Validation Specialist · M-F 1st shift · Summary: · In this critical position, the Validation Specialist is responsible for authoring and executing installation, operation and performance process and equipment qualifications (IOPQ)for the site to ensure complian ...
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Validation Specialist
3 weeks ago
Catalent Inc Princeton, United StatesIn this critical position, · the Validation Specialist · is responsible for authoring and executing installation, operation and performance process and equipment qualifications (IOPQ)for the site to ensure compliance with local and global regulatory agency requirements, interna ...
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Validation & Documentation Specialist
5 hours ago
ATS Automation Warminster, United StatesATS Company: SP Industries · Requisition ID: 12489 · Location: · Warminster, PA, US, 18974 · Date: Jun 18, 2024 · Validation & Documentation Specialist · ATS Scientific Products is seeking a full?time Validation and Documentation Specialist in Warminster, PA to create and m ...
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Validation Specialist
3 weeks ago
PCi Corporation Philadelphia, United StatesRed Lion Road-PA002 · SUMMARY: · The main functions of a Validation Specialist are focused around the qualification of pharmaceutical packaging equipment and validation of the associated processes run on this equipment. These functions include generation and execution of protocol ...
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Validation & Documentation Specialist
1 day ago
ATS Automation Warminster, United StatesATS Company: SP Industries Requisition ID: 12489 Location: Warminster, PA, US, 18974 · #job- { display: inline; } Date: Jun 18, 2024 Validation & Documentation Specialist · ATS Scientific Products is seeking a full‐time Validation and Documentation Specialist in Warminster ...
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Validation Engineer/Specialist
1 week ago
IPS-Integrated Project Services, LLC Somerset, United StatesJob Description: · At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer/Specialist to join our talented team at our office located ...
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Senior Validation Specialist
2 weeks ago
Katalyst Healthcares and Life Sciences Cranbury, United StatesResponsibilities: Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation. · Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interp ...
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Validation Specialist
1 month ago
Catalent Pharma Solutions Princeton, United States Paid WorkPosition Title:Validation Specialist · M-F 1st shift · Summary: · In this critical position, the Validation Specialist is responsible for authoring and executing installation, operation and performance process and equipment qualifications (IOPQ)for the site to ensure compliance ...
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WuXi AppTec Philadelphia, United StatesOverview · Primary resource for the development, execution, review, and approval of equipment/software validations (including Computerized Laboratory Systems), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change Co ...
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Instrument Validation Specialist
4 weeks ago
EY Lansdale, United States FreelanceWe currently have a contract opportunity for an Instrument Validation Specialist - Contractor to assist our client with the validation of their laboratory equipment through a hybrid work schedule. · Develop, review, and execute validation protocols for laboratory instruments, in ...
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Instrument Validation Specialist
4 weeks ago
Kaygen Lansdale, United StatesKAYGEN is an emerging leader in providing top talent for technology based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Servic ...
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Product Validation Specialist
3 weeks ago
Ace American Insurance Philadelphia, United StatesProduct Validation Specialist - 8373 · DESCRIPTION/RESPONSIBILITIES: In this role, you will work closely with the NA Digital Consumer Team, product owners, Tech Team, and other members of the Operations group in testing, implementing, and managing products, processes, user accept ...
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Validation & Documentation Specialist
3 weeks ago
SP Industries Warminster, United StatesSP Industries Inc. · Validation & Documentation Specialist · Warminster , · Pennsylvania · Apply Now · ATS Scientific Productsis seeking a full-time Validation and Documentation Specialist in Warminster, PA to create and maintain various technical documents (e.g., user manua ...
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Katalyst Healthcares and Life Sciences Raritan, United StatesResponsibilities : This role will require CQV and engineering experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to support timely completion of the CQV activities [i.e, Controlled Tempe ...
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Instrument Validation Specialist
2 weeks ago
Kaygen Lansdale, United States· KAYGEN is an emerging leader in providing top talent for technology based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Ser ...
Validation Specialist - Trenton, United States - Integrated Resources
Description
Job Title:
Validation Specialist
Job Location:
Warren, NJ
Job Duration: 5 Months
Work Schedule:
Mon - Fri, Business Hours
Job Description:
The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems
Primary responsibilities include:
qualification of laboratory instruments, setup of computers and instruments, troubleshooting of system related issues, and technical writing and execution.
Executes validation projects, system qualification, and implements industry best practices for the design and delivery of GxP computerized systems.Required Competencies:
Knowledge, Skills, and Abilities:
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Working understanding of validation concepts and requirements.
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Intermediate written and verbal communication skills.
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Knowledge of cGMP.
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Critical reasoning and decision making skills.
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Knowledge of validation industry and regulatory requirements.
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Ability to work independently and participate in a team.
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Work and time management skills.
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Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.
Duties and Responsibilities:
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Performs validation document generation, program management, and protocol execution activities.
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Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
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Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
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Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
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Protocol execution and project activities.
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Execute qualification activities with oversight.
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Participate in department and site project teams.
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Perform qualification activities according to site objectives and timelines.
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Edit department SOPs and generate basic revisions as required.
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Execute CAPA plans, risk assessments, investigations, and root cause analysis.
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Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
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Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
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Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
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Performs general administrative and organizational activities.
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Management of time and work deliverables, regular interface and reporting to management.
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Complete regulatory, site, and department training requirements on a timely basis.
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Perform other tasks as assigned.
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