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    Validation - Validation Specialist

    Artech Llc
    8+ years
    Not Disclosed
    Warren Grove
    12 May 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Validation Specialist

    Location

    • Warren, NJ
    • Work Schedule: Mon - Fri, Business Hours
    • Duration: 6 months contract
    • Onsite

    Job Description

    The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Key responsibilities include qualification of laboratory instruments, setup of computers and instruments, troubleshooting of system-related issues, and technical writing and execution. This role involves executing validation projects, system qualification, and implementing industry best practices for the design and delivery of GxP computerized systems.

    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.
    • Proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.

    Duties and Responsibilities

    • Perform validation document generation, program management, and protocol execution activities.
    • Interface with Engineering and end-user groups to support the development of life cycle documents and system requirements.
    • Design validation approaches with technical oversight, provide scientific rationale and acceptance criteria, and generate validation protocols.
    • Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
    • 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.
    • Understand 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.
    • Manage time and work deliverables, regularly interface, and report to management.
    • Complete regulatory, site, and department training requirements on a timely basis.
    • Perform other tasks as assigned.

    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.

    Working Conditions

    • The incumbent may be required to gown and operate in classified manufacturing environments.

    Apply Now

    • Job Type: Permanent
    • Job ID: 157365163

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    About Us

    • Company: Katalyst Healthcares & Life Sciences
    • Industry: Clinical trials of drugs, biologics, and medical devices.

    Additional Information

    For more information or to apply, please contact Human Resources.

     

     

     

     

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