Validation Specialist
2 weeks ago
Job 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 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.
Benefits
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.
#M3
#J-18808-Ljbffr
-
Validation Specialist
2 weeks ago
Trenton, United States Integrated Resources Full timeJob 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...
-
Validation Specialist
7 days ago
Trenton, United States Synkriom Full timeJob 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 instruments, troubleshooting of system related issues, and technical writing...
-
Validation Specialist
1 week ago
Trenton, United States Integrated Resources Full timeJob 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 systems. Primary responsibilities include: qualification of laboratory instruments,...
-
Validation Specialist
2 weeks ago
Trenton, United States Knewin Full timeJob 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: qualification of laboratory instruments, setup of computers and instruments,...
-
Validation Specialist
2 weeks ago
Trenton, United States System One Full timeJob 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 end user groups to support development of life cycle documents and system requirements. Design the...
-
Validation Specialist
6 days ago
Trenton, United States Pyramid Consulting Full timeImmediate 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: 24-21500 Pay Range: $55 - $62/hour. Employee benefits include, but are not limited to, health insurance...
-
Validation Specialist
4 days ago
Trenton, United States PharmaLex Full timeJOIN 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 exciting career opportunities in an atmosphere that values trust, respect, teamwork,...
-
Senior Validation Specialist
4 days ago
Trenton, United States Ferring Holding SA Full timeSenior 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 R0027187 Job Description: As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and...
-
Software Validation Specialist
4 days ago
Trenton, United States Binaryitech Full timeThe 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 audits. Act as a QA approver for internal validation efforts. Serve as a liaison to the...
-
Computer Systems Validation Specialist
6 days ago
Trenton, United States LabVantage Full timeLabVantage 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 and solutions, to address growing customer needs. As a key member of the LabVantage PSO team,...
-
Trenton, United States American Cybersystems Full timeInnova Solutions is immediately hiring a Validation Specialist Job Title: Validation Specialist Position type: Full-time Contract Duration: 12 Months Location: Warren, NJ Onsite As a Validation Specialist, you will: This role supports the successful operation of facilities, laboratories, and business functions at multi-use sites through interaction with...
-
Validation Specialist
2 weeks ago
Trenton, United States System One Holdings Llc Full timeJob 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 development of life cycle documents and system requirements.Design the...
-
Validation Specialist
2 weeks ago
Trenton, United States System One Full timeJob 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 development of life cycle documents and system requirements.Design the...
-
Validation Engineer/Specialist
5 days ago
Trenton, United States IPS-Integrated Project Services, LLC Full timeJob 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 to join our talented team at our office located in Somerset, New Jersey . In this role, you will perform cGMP compliance-based services...
-
Qualification Specialist
2 weeks ago
Trenton, United States Synkriom Full timeJob DescriptionJob Description Commissioning/Qualification Specialist/Validation 100% Onsite --Warren, NJ--Local candidates only Work Schedule: Mon - Fri, Business Hours'' DUTIES AND RESPONSIBILITIES 1) Commissioning and Qualification: a. Administer change control activities and corrective and preventive actions. b. Review, approve, and execute test...
-
Loss Control Specialist
1 month ago
Trenton, United States The Andover Companies Full timeLoss Control Specialist - this position is located in both New Jersey (Northern or Central) and the New York City Metropolitan areas. We are looking for a Loss Control Specialist to join our team! Founded in 1828, The Andover Companies is an A (Excellent) rated property and casualty insurance organization writing approximately $600M+ in premium, with $2B in...
-
Intervention Specialist
4 weeks ago
Trenton, United States Butler County Area Application Consortium Full timePosition Type: Intervention SpecialistDate Posted: 3/14/2024Location: Edgewood Middle SchoolDistrict: Edgewood City Schools - websiteEdgewood Middle School Intervention Specialist 2024/2025 School Year QUALIFICATIONS High School Diploma or equivalent Valid Driver's license Appropriate State of Ohio Teaching License A satisfactory report from Criminal...
-
Intervention Specialist
4 weeks ago
Trenton, United States Butler County Area Application Consortium Full timePosition Type: Intervention SpecialistDate Posted: 3/14/2024Location: Edgewood High SchoolDistrict: Edgewood City Schools - websiteEdgewood High School Intervention Specialist 2024/2025 School Year QUALIFICATIONS High School Diploma or equivalent Valid Driver's license Appropriate State of Ohio Teaching License A satisfactory report from Criminal Records...
-
Intervention Specialist
4 weeks ago
Trenton, United States Butler County Area Application Consortium Full timePosition Type: Intervention SpecialistDate Posted: 1/2/2024Location: Edgewood Middle SchoolDistrict: Edgewood City Schools - websiteEdgewood Middle School Intervention Specialist 2024/2025 School Year QUALIFICATIONS High School Diploma or equivalent Valid Driver's license Appropriate State of Ohio Teaching License A satisfactory report from Criminal...
-
Infant Toddler Development Specialist
3 days ago
Trenton, United States Childrens Home Society of Florida Full timeOverview: **Since opening our doors in 1902, CHS became a part of Florida's history.** CHS has been committed to growing and evolving to provide the right services and solutions to address the needs of children and families throughout the changing times. Every day, our team works with parents and kids to empower them and encourage them. With innovative...