- 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.
- 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.
- Management of time and work deliverables, regular interface and reporting to management.
- Complete regulatory, site, and department training requirements on a timely basis.
- 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.
- Working Conditions
- The incumbent may be required to gown and operate in classified manufacturing environments.
-
Validation - Validation Specialist
3 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 ...
-
Validation - Validation Specialist
3 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 ...
-
Validation - Validation Specialist
2 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 ...
-
Validation - Validation Specialist
2 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 ...
-
Validation Specialist
1 week ago
PCI Pharma Services Philadelphia, United StatesLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. · We are PCI. · Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pi ...
-
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 Specialist · Pay: $ $61.50/hour · Location: 100% Onsite in Warren, NJ - local candidates only · Term: 6-month contr ...
-
Validation Specialist
2 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 ...
-
Validation Specialist
1 week ago
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 ...
-
Validation Specialist
1 week 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 ...
-
Validation Specialist
3 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 ...
-
Validation Specialist
1 week 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 compute ...
-
Validation Specialist
2 weeks ago
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: ...
-
Validation Specialist
2 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 ...
-
Validation Specialist
3 weeks ago
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 ...
-
Validation Specialist
2 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 ...
-
Validation Specialist
2 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 ...
-
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: ...
-
Validation Specialist
2 weeks ago
System One Trenton, United StatesHours/Schedule: Mon - Fri, Business HoursType: ContractResponsibilitiesPerforms 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 requirem ...
-
Validation Specialist
3 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
2 weeks ago
System One Trenton, United StatesHours/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 sys ...
Validation Specialist - Trenton, United States - Knewin
Description
Job 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 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:
Duties and Responsibilities:
Education and Experience:
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
Additional Job Requirements:
Lab w/o blood & animal
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
#J-18808-Ljbffr
