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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:
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.
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.
Qualifications
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
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
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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