Sign upLog in
See more jobs

Validation Specialist

TechDigital
  • West Point, PA
    30+ days ago

    Job Description

    Validation Specialist (Life Sciences)
    • Develop and maintain SOPs, user manuals, validation protocols, and regulatory submission documents.
    • Translate complex scientific and technical concepts into clear, concise documentation.
    • Collaborate with SMEs to gather and verify technical information.
    • Ensure documentation complies with industry standards (GxP, ISO, ICH).
    • Manage document lifecycle using electronic document management systems (EDMS).
    • Author and execute validation protocols (IQ/OQ/PQ) for equipment, software, and processes.
    • Perform Computer System Validation (CSV) in accordance with 21 CFR Part 11 and GAMP 5.
    • Conduct risk assessments and support change control processes.
    • Review and approve validation documentation and reports.

    Numbers & Facts

    LocationWest Point, PA
    IndustryOther/Not Classified
    Company Size100 to 499 employees

    Skills

    • Biologyunmatched
    • Change Controlunmatched
    • Code of Federal Regulationsunmatched
    • Computer Systemsunmatched
    • Documentationunmatched
    • Process Validationunmatched
    • Regulatory Submissionsunmatched
    • Risk Analysisunmatched
    • Standard Operating Procedures (SOP)unmatched
    • System Validationunmatched
    • User Documentationunmatched
    • Validation Documentationunmatched
    • Validation Planunmatched
    • Writing Skillsunmatched

    Level up your application

    Professional resume templates

    Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.

    Free resume templates

    Resume Builder

    Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.

    Resume Builder