Primary 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: $56.00 - $61.50/hour
Location: 100% Onsite in Warren, NJ - local candidates only
Term: 6-month contract (possibility of extension/conversion to FTE, depending on performance)
Work Schedule: Mon - Fri, Business Hours
Note: No C2C or sponsorship is provided
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 and execution. Executes validation projects, system qualification, and implements industry best practices for the design and delivery of GxP computerized systems.
Education And Experience
Bachelor's degree preferred, preferably in Science or Engineering.
8 Years Of Relevant Work Experience Required.
An equivalent combination of education, experience, and training may substitute.
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.
Duties And 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.
Working Conditions
The incumbent may be required to gown and operate in classified manufacturing environments.
Lab w/o blood & animal
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at (url removed)
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