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Automation / CSV Lead

Pharmatek Consulting
  • New Brunswick, New Jersey
    30+ days ago

    Job Description

    The Automation/CSV Lead will manage the qualification of automation systems, including DeltaV, BMS, BAS, and EMS, as well as CSV for production equipment and analytical instruments. This role requires a deep understanding of automated control systems and experience in computerized systems validation (CSV).


    Key Responsibilities:
    ​

    • Develop and execute protocols for automation systems including DeltaV, BMS, BAS, and EMS.

    • Perform CSV for production equipment and analytical instruments.

    • Collaborate with engineering and CQV teams to align automation validation activities with project timelines.

    • Conduct risk assessments and implement mitigation strategies for computerized systems.

    • Oversee documentation lifecycle for CSV activities, ensuring compliance with regulatory standards.



    Requirements

    Qualifications:

    • Bachelor’s degree in Computer Science, Engineering, or a related field.

    • 10+ years of experience in automation and CSV within the pharmaceutical industry.

    • Expertise in DeltaV, Building Management Systems (BMS), BAS, and Environmental Monitoring Systems (EMS).

    • Strong knowledge of GAMP5, FDA regulations, and 21 CFR Part 11.

    • Excellent technical documentation and project management skills.



    Numbers & Facts

    LocationNew Brunswick, New Jersey
    Websitewww.consultpharmatek.com

    Skills

    • Analysis Skillsunmatched
    • Automationunmatched
    • Automation Systemsunmatched
    • Biotech and Pharmaceuticalunmatched
    • Code of Federal Regulationsunmatched
    • Computer Scienceunmatched
    • Control Systemsunmatched
    • DeltaVunmatched
    • Documentationunmatched
    • Environmental Monitoringunmatched
    • FDA Requirementsunmatched
    • Maintain Complianceunmatched
    • Project/Program Managementunmatched
    • Property Managementunmatched
    • Regulatory Complianceunmatched
    • Risk Analysisunmatched
    • System Validationunmatched
    • Technical Writingunmatched

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