Cleaning Validation Engineer II

ID# DCPA28706

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

JOB OVERVIEW 

The Cleaning Validation Engineer II 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. Experience troubleshooting CIP system failures, optimizing CIP/COP systems including manual processes and CIP equipment, developing CIP/COP Cycles is preferred. Experience Developing documents and SOPs and prepare reports is required. Must have experience 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. 

Education: 

A minimum of a Bachelor's Degree is required. An advanced degree is preferred. A focused degree in Science or Engineering is required. 

Experience/Technical Competencies: 

A minimum of 4 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 preferred. Strong organizational skills and demonstrated ability to manage projects to completion are highly desired. Experience in discrepancy and non-conformance reporting, corrective action/preventive action systems and root cause analysis is preferred. Proven skills in Microsoft Office applications is required. 

Job Knowledge/Skillset: 

  • Strong Demonstrated problem solving and decision making skills 
  • Ability to understand and extract necessary information from technical documents 
  • Ability to handle complex projects 
  • Takes initiative to help drive projects forward and develop contingency plans when applicable 
  • Ability to work on cross-functional project teams 
  • Able to effectively manage workload and prioritize activities 
  • Excellent verbal and written communication skills 
  • Proven ability to review, interpret and make scientific conclusions and recommendations based on data 
  • Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals 
  • Effectively work within a team environment and interface with peers, management, etc. 
  • Strong computer skills, including experience using Microsoft Word, Excel, PowerPoint and Visio.

 

Position Details:

Consumer Product

Engineering

Start Date: 
1-7-2013
End Date: 
9-30-2013

LANCASTER, PA

CON_W2

40

DCPA28706

No

No