Senior Consultant - Lead for Cleaning Validation

Senior Consultant – Lead for Cleaning Validation
 
PharmEng is currently looking for a Senior Consultant – Lead for Cleaning Validation to join our team as a Subject Matter Expert (SME) for the United States (US) region.
 
Job Description:
  • SME to analyze process gaps, revive their current method of cleaning, review the current program and recommend changes and work with the team to move forward with training of the new program.
  • Perform gap assessments by reviewing current cleaning validation strategies and validation master plan and make necessary recommendations.
  • Create final reports outlining findings and recommendations.
  • Post cleaning validation monitoring, cleaning cycle development and cleaning validation in a cGMP facility.
  • Maintain all documentation pertaining to cleaning cycle development and validation.
  • Participate in cleaning cycle development activities including parameter selection, determining order of operations, troubleshooting, sampling, and data analysis.
  • Coordinates validation execution between all involved departments.
  • Independently follows-up and resolves comments, deviations, and technical issues.
  • Authors development and validation protocols, SOPs, and reports.
Job Requirements:
  • 10+ years of Cleaning Validation experience in Pharmaceutical/Biotech Industry, with experience responding to FDA.
  • Bachelor's degree or higher in Engineering, Life Sciences or related discipline (Engineering, Chem Eng, Chemistry, Biology, etc.).
  • Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities.
  • Thorough knowledge of cGMP regulations and clean room environment.
  • Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports.
  • Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills.
  • Must have strong ability to organize and manage multiple tasks in a fast-paced environment.

 
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
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