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Validation - Validation Specialist
3 weeks ago
TechDigital Corporation Trenton, United StatesSenior Validation Specialist · Warren, NJ--Onsite · Work Schedule: Mon - Fri, Business Hours · The Senior Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities ...
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Validation - Validation Specialist
4 weeks ago
HonorVet Technologies Trenton, United StatesJob Description: Validation Specialist · Warren, NJOnsite · Work Schedule: Mon - Fri, Business Hours · The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities ...
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Validation Specialist
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Synkriom Trenton, United StatesJob Description · 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 compute ...
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Validation - Validation Specialist
3 weeks ago
TechDigital Corporation Trenton, United StatesSenior Validation SpecialistWarren, NJ--OnsiteWork Schedule: Mon - Fri, Business HoursThe Senior Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qu ...
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Validation - Validation Specialist
4 weeks ago
HonorVet Technologies Trenton, United StatesJob Description: Validation SpecialistWarren, NJOnsiteWork Schedule: Mon - Fri, Business HoursThe Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: q ...
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Senior Validation Specialist
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Ferring Holding SA Trenton, United StatesSenior Validation Specialist page is loaded Senior Validation Specialist Apply locations Parsippany, New Jersey, United States time type Full time posted on Posted 7 Days Ago job requisition id R Job Description: As a privately-owned, biopharmaceutical company, Ferring pioneers a ...
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Software Validation Specialist
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Binaryitech Trenton, United StatesThe Software Validation Specialist will collaborate closely with the Clinical Quality Assurance Lead for Systems Audits, focusing on audit and quality · Participate in computer system audits to review SDLC and data integrity controls. · Review CAPA and verify CAPAs of system audi ...
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Validation Specialist
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Primary Talent Partners, Inc. Trenton, United StatesPrimary Talent Partners has a 6-month contract opening for a Validation Specialist with one of our pharmaceutical clients in Warren, NJ. · Job Title: Validation Specialist · Pay: $ $61.50/hour · Location: 100% Onsite in Warren, NJ - local candidates only · Term: 6-month contr ...
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Validation Specialist
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Knewin Trenton, United StatesJob Description: Validation SpecialistWarren, NJ--OnsiteWork Schedule: Mon - Fri, Business HoursThe Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: ...
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Validation Specialist
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Pyramid Consulting Trenton, United StatesImmediate need for a talented · Validation Specialist . This is a · 06+ Months Contract · opportunity with long-term potential and is located in · Warren, NJ(Onsite) . Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay Range: ...
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Validation Specialist
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Integrated Resources Trenton, United StatesJob Title: Validation SpecialistJob Location: Warren, NJJob Duration: 5 MonthsWork Schedule: Mon - Fri, Business HoursJob Description:The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized syst ...
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Validation Specialist
3 weeks ago
Primary Talent Partners Inc. Trenton, United StatesPrimary Talent Partners has a 6-month contract opening for a Validation Specialist with one of our pharmaceutical clients in Warren, NJ.Job Title: Validation SpecialistPay: $ $61.50/hourLocation: 100% Onsite in Warren, NJ - local candidates onlyTerm: 6-month contract (possibility ...
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Validation Specialist
3 weeks ago
Synkriom Trenton, United StatesJob Description 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 ...
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Validation Specialist
3 weeks ago
Knewin Trenton, United StatesJob Description: Validation Specialist · Warren, NJ--Onsite · Work Schedule: Mon - Fri, Business Hours · The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilitie ...
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Validation Specialist
3 weeks ago
System One Holdings, LLC Trenton, United StatesJob Title : Validation Specialist · Location : Warren, NJ · Hours/Schedule : Mon - Fri, Business Hours · Type: · Contract · Responsibilities · Performs validation document generation, program management, and protocol execution activities. · Interface with Engineering, and en ...
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Validation Specialist
4 weeks ago
Rangam Trenton, United StatesPay Scale: $60.00 -$63.00 per Hourly · Job Description: · 100% Onsite in Warren, NJ · Lab w/o blood & animal · Duties: · The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. · Prim ...
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Validation Specialist
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PharmaLex Trenton, United StatesJOIN OUR TEAM · PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing excitin ...
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Validation Specialist
3 weeks ago
Pyramid Consulting Trenton, United StatesImmediate need for a talented Validation Specialist . This is a 06+ Months Contract opportunity with long-term potential and is located in Warren, NJ(Onsite) . Please review the job description below and contact me ASAP if you are interested.Job ID: Pay Range: $55 - $62/hour. Emp ...
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Validation Specialist
2 weeks ago
Integrated Resources Trenton, United StatesJob 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 ...
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Validation Specialist
4 weeks ago
Joule Trenton, United StatesJob Title: Validation SpecialistLocation: Warren, NJHours/Schedule: Mon - Fri, Business HoursType: ContractResponsibilitiesPerforms validation document generation, program management, and protocol execution activities.Interface with Engineering, and end user groups to support dev ...
Validation Specialist - Trenton, United States - System One
Description
Hours/Schedule:
Mon - Fri, Business Hours
Type:
Contract
Responsibilities
Performs validation document generation, program management, and protocol execution activities.
Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
Protocol execution and project activities.
Execute qualification activities with oversight.
Participate in department and site project teams.
Perform qualification activities according to site objectives and timelines.
Edit department SOPs and generate basic revisions as required.
Execute
CAPA plans, risk assessments, investigations, and root cause analysis.
Working understanding of site quality GxP systems supporting document management, change controls, deviations,
CAPAs.
Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
Performs general administrative and organizational activities.
Management of time and work deliverables, regular interface and reporting to management.
Complete regulatory, site, and department training requirements on a timely basis.
Perform other tasks as assigned.
Requirements
Required Competencies:
Knowledge, Skills, and Abilities:
Working understanding of validation concepts and requirements.
Intermediate written and verbal communication skills.
Knowledge of cGMP.
Critical reasoning and decision making skills.
Knowledge of validation industry and regulatory requirements.
Ability to work independently and participate in a team.
Work and time management skills.
Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.
CAPA
GXP System Validation/21CFR Part 11.
Education and Experience:
Bachelor's degree preferred, preferably in Science or Engineering.
8 years relevant work experience required.
An equivalent combination of education, experience and training may substitute.
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
#M3System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America.
We help clients get work done more efficiently and economically, without compromising quality.System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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