Cleaning Validation Engineer III

ID# DCPA30303

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise.

The Cleaning Validation Engineer III will work on projects in the Lancaster area. The position involves post cleaning validation monitoring, cleaning cycle development and cleaning validation in a cGMP facility. Experience in CIP/COP and manual cleaning validation activities are required. The following experience is also required: troubleshoot CIP system failures optimize CIP/COP systems including manual processes and CIP equipment, develop CIP/COP Cycles, develop documents and SOPs and prepare reports. 
Must be able to analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures. Generate and resolve protocol discrepancies or deviations. Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation. Train operations staff on protocols, procedures and technical details related to systems or processes. Organize, schedule and track validation projects in order to meet client requirements and agreed timelines

Experience/Technical Competencies: 

  • A minimum of 6 years’ experience in Biotech or Pharmaceutical industries is required.
  • Hands-on experience with the following systems: CIP systems, cabinet washers, COP, manual cleaning is required. Experience with sampling techniques.
  • Working knowledge of cGMP requirements and strong written and verbal communication skills are required for this position.
  • Experimental design and problem solving skills are required.
  • Experience in discrepancy and non-conformance reporting, corrective action/preventive action systems and root cause analysis is required.

 

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Manual cleaning exp.- writing protocols, reports and procedures for performing manual cleaning

Position Details:

Pharmaceutical

Engineering

Start Date: 
2-12-2014

Lancaster, PA

Full Time

DCPA30303

No

No