Senior Validation Specialist
Senior Validation Specialist
On-Board Companies
Warren, NJ
See who On-Board Companies has hired for this role
On-Board Scientific is hiring a Senior Validation Specialist based out of Warren, NJ!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are located.About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Senior Validation Specialist
Position Type: 1 year contract with additional opportunity contingent upon performance and continued business need
Job Location: Warren, NJ
Pay Rate: $61.94 per hour.
100% onsite role
The Senior Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems.
Primary responsibilities include:
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
All candidates must complete background and drug screenings prior to start.
On-Board Companies provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.
INDOJ
24-00652
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are located.About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Senior Validation Specialist
Position Type: 1 year contract with additional opportunity contingent upon performance and continued business need
Job Location: Warren, NJ
Pay Rate: $61.94 per hour.
100% onsite role
The Senior Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems.
Primary responsibilities include:
- 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.
- 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.
- 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 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
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
All candidates must complete background and drug screenings prior to start.
On-Board Companies provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.
INDOJ
24-00652
-
Seniority level
Entry level -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Business Consulting and Services
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