Jobs · Engineering · Colorado

CIP Engineer / Consultant

Stark Pharma Solutions Inc · Boulder, CO · 2 wk ago
EngineeringFull-time

About the Role

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.

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.

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.

Location: Colorado
Duration: Long Term

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