Validation - Qualification Engineer

Highly Competitive
  1. Permanent
  2. Validation
  3. Switzerland
Lausanne
Posting date: 15 Apr 2019
EN.JF.22781_1555326395

ProClinical is partnering with a leading pharmaceutical company to advertise a vacancy for a Validation-Qualification Engineer position. The Validation-Qualification Engineer will provide (SME) subject matter expert support to the business. This job will be based in the company's office in Switzerland.

Job Responsibilities:

  • Validating, qualifying, and commissioning existing and new equipment, processes, data, and documentation.
  • Preparing and completing validation documentation/protocols (IQ, OQ, PQ, DQ, FAT, SAT, URS).
  • Assisting in the development of Master Validation Plan, for defined projects.

Skills and Requirements:

  • At least 7 years of experience within an engineering department of a highly regulated process industry.
  • Experience System/Process/Equipment/Cleaning within the Biotech/MedDevice/Pharmaceutical (FDA/MHRA regulated industries).
  • Strong cGMP, GAMP, and GxP knowledge.
  • Knowledge of FDA 21 CFR Part 11, Annex 11 regulation.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Jay Foster at +44 203 752 0309 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.

#LI-JF1

#HEOR

close