Description
Senior Validation Engineer - Cold Chain, Lab Equipment, Kaye Validator 2000 - CONTRACT
Location: Midlands, UK
Duration: 12 months +
Rate: Ideally £ per day
My exclusive customer urgently requires the services of an experienced Pharmaceutical Senior Validation Engineer to join their new project team on a 12 month Contract basis. The Senior Validation Engineer will be responsible for qualification and validation activities related to experimental production and Quality Control Laboratories.
Essential Skills/experience required:
* Bachelor's degree in Engineering or Science field ie, Engineering, Pharmacy, Chemistry, Biochemistry with high and comprehensive know how in validation activities and pharmaceutical technology
* Minimum of 4-5 years direct experience in a validation role in Pharmaceutical/Biopharmaceutical or Medical Device industry preferred.
* Technical Skills - Sound working knowledge of Cold Chain, Computer systems and the operation of various processing equipment, for example (but not limited to) the following: laboratory equipment (HPLCs, Disolutors, GCs, TOC analyzers, stability chambers, sterilizers, ovens, incubators, etc) HVAC systems, freezers, refrigerators, assembly equipment, labeling/packaging equipment, ancillary and integrated inspection equipment, multipoint recorders, voltmeters, etc
* Sound use of a Kaye Validator 2000 System 2.33v or higher (including report generation)
* A strong working knowledge of equipment calibrations
* Strong knowledge of cGMP. GDPs, CSV/GAMP, 21CFR Part 11, Annex 11, Project Life Cycle quality systems, and general knowledge of associated industry and regulatory guidance documents; FDA/EMEA/ANVISA Guidelines, PDA Tech. Monographs, ISPE, etc, and proven ability to apply guidelines to all aspects of qualification activities.
* Knowledge/understanding of protocol acceptance criteria and is able to readily identify/report deviations to management in a timely manner.
* Strong technical writing ability. Writes clearly and informatively, able to express complex ideas in a clear, concise manner; capable of explaining technical issues to non-technical personnel.
* Experience with cold chain qualifications and Aseptic/Sterile Manufacturing and/or Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries is preferred
* Experience in managing complex validation projects in a fast paced environment is required.
* Experience of Technology Transfer, Process Scale up and process improvement projects preferable.
CPS Group (UK) Ltd is acting as an Employment Business in relation to this vacancy.