CIP Engineer / Consultant

Stark Pharma Solutions Inc

  • Boulder, CO
  • 2 days ago

    Highlights

    Develop and optimize Clean-in-Place (CIP) cleaning cycles for process vessels and lines, chromatography skids/columns, UF/DF skids, centrifuges, glass/parts washers, and portable processing equipment. We are seeking an experienced CIP Engineer / Consultant to support cleaning cycle development, commissioning, qualification, and validation activities within a pharmaceutical/GMP manufacturing environment.

    Numbers & Facts

    LocationBoulder, CO

    Description

    Position: CIP Engineer / Consultant
    Location: Colorado
    Duration: Long Term

    Job Overview

    We are seeking an experienced CIP Engineer / Consultant to support cleaning cycle development, commissioning, qualification, and validation activities within a pharmaceutical/GMP manufacturing environment. The ideal candidate will have strong hands-on experience with CIP systems and circuits, cleaning validation, process equipment, and pharmaceutical manufacturing systems.

    Key Responsibilities

    • Develop and optimize Clean-in-Place (CIP) cleaning cycles for process vessels and lines, chromatography skids/columns, UF/DF skids, centrifuges, glass/parts washers, and portable processing equipment.
    • Perform commissioning activities and provide automation support for CIP systems, including PLC and SCADA/DeltaV systems.
    • Develop, execute, and document cleaning validation protocols and generate summary reports.
    • Prepare and maintain documentation in accordance with Good Documentation Practices (GDP).
    • Consult with clients and vendors regarding technical issues, major problems, and project developments.
    • Review engineering specifications for compliance with applicable engineering requirements and standards.
    • Perform batch record reviews, including verification of calibration and in-process data.
    • Review piping designs and flow calculations for CIP systems.
    • Support troubleshooting and resolution of CIP system and circuit issues.
    • Support commissioning, qualification, and validation of pharmaceutical manufacturing equipment.
    • Provide technical support for CIP cycle development, optimization, and cleaning processes.

    Required Qualifications

    • Minimum 3 years of pharmaceutical manufacturing or GMP environment experience.
    • Bachelor's degree in Chemical Engineering or a related field.
    • Hands-on experience with CIP systems and CIP circuits.
    • Experience with cleaning validation, protocol development, execution, and summary reports.
    • Experience with CIP troubleshooting is preferred.
    • Familiarity with cleaning of pharmaceutical process equipment, CIP cycle development and optimization, piping design, and fluid dynamics.
    • Minimum 3 years of Commissioning, Qualification, and Validation (CQV) experience with pharmaceutical manufacturing equipment.
    • Familiarity with PLC and SCADA/DeltaV plant control systems.
    • Strong written and verbal communication skills.
    • Strong computer skills, including Microsoft Office.
    • Willingness to travel as required.

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