Fellbach: +49 711 34 24 37-0 Düsseldorf: +49 211 138 66 37-0 kontakt@expertalis.de

Wanted: Your experience in the pharmaceutical industry


Our client is an internationally operating services group.   From the headquarters in Rotterdam area/Netherlands, the company offers a full range of services for the (Bio-)Pharmaceutical, High-End Food and Oil, Gas & Chemicals industry, including Asset Management, Integrated Commissioning & Validation, Interim/Project Management and Process Development.
To manage the fast groth of this company, we are offering a full time employment for a long term project in Visp (canton Valais) in Switzerland as a

Senior Qualification & Validation Engineer (f/m/d) Visp/Switzerland

Your benefits

For our consultancy services we are looking to recruit a hands-on Senior Qualification & Validation engineer. Experience and track record within the pharmaceutical industry (production) is a must. We offer a challenging, varied and technical job with ample opportunities for personal contribution and development.


Your tasks

  • Experience with the start-up of process equipment using commissioning protocols. Writing & reviewing these protocols is part of the job. Troubleshooting during start-up phase. Responsible for input into (re)constructing contractor package
  • This complete process should be documented well. From Commissioning we will go (integrated) to the next phase of qualification
  • Design, develop, execute and write IQ/OQ/PQ validation protocols and reports according to standards and guidelines for the pharmaceutical industry. Archive the relevant reports
  • Analyze and interpret validation data, results and summarize findings in final reports
  • Analyze the design to identify the GMP requirements for validation
  • Resolve protocol and execution discrepancies to a satisfactory conclusion and plan follow up actions as required
  • Make recommendations and decisions (when appropriate) regarding test strategies and approaches
  • Conducting and coordinating validation testing

Your qualifications:

Education:

  • Chemical engineering or mechanical engineering (Bachelor or Masters degree) or other relevant education and 5 – 10 years relevant experience

Skills:

  • In depth knowledge of CGMP or GxP
  • Technical project experience; Implementation of commissioning, qualification or validation. Planning and supervising the production of developmental products and the transfer of new products to production. Acting as an interface between development, engineering and quality assurance
  • Experience in writing, executing, and summarizing validation protocols and SOPs for pharmaceutical manufacturing installations
  • Knowledge of validation regulatory and industry standards and guidelines
  • Experience in validating clean utility systems (WFI, PW, CCS etc)
  • Experience with process equipment
  • Detailed knowledge of commissioning and validation requirements within regulatory environments
  • Fluent in spoken and written English and/or Dutch
  • Good knowledge of MS Office software

Personality:

  • Team player, but also able to work independent
  • Strong analytical and technical writing skills
  • Excellent communication and interpersonal skills
  • Anticipating attitude (is a must)
  • Persistence
  • Flexible
  • Customer and result orientated

If we have been able to arouse your interest with this challenge, we look forward to receiving detailed application documents stating your salary expectations and notice period, as well as the position number 3413 to bewerbung@expertalis.de.  


We look forward to receiving your application!