CQV Engineer

Up to US$70.00 per hour
  1. Contract
  2. Project Engineering
  3. United States
Topeka, Kansas
Posting date: 21 Feb 2019

ProClinical are working exclusively with an Engineering Consultancy who specialize in the C&Q stages of greenfield projects. This organisation is seeking a CQV Engineer to join their team in Kansas on a contract basis.

The consultancy is currently supporting a large pharmaceutical company that develop and manufacture sterile injectables. This is an exciting opportunity to support a highly skilled C&Q team that is expanding its presence in the US.

Job Responsibilities:

  • Developing and executing CQV protocols for a Bosch Cartridge Filler and its associated equipment.
  • Developing CQV planning documents to manage CQV projects.
  • Developing and executing CQV protocols using Good Documentation Practices (GDPs).
  • Investigating and resolving protocol exceptions or discrepancies.
  • Developing technical reports and CQV summary reports.
  • Reading and verifying facility and equipment drawings, (e.g., P&IDs, AF&IDs, etc.)
  • Developing Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation.
  • Performing risk assessments and impact assessments.
  • Applying engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients.

Skills and Requirements:

  • A university degree in a relevant field.
  • Previous experience working with CQV equipment such as Auto Claves, Bioreactors, Freezers, Tunnels.
  • Experience in HVAC, CQV.
  • Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, persuasion, influence, and leadership.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Joseph Emmott on +44 203 814 1316 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.