Senior CSV Engineer - Biotech

Senior CSV Engineer - Biotech

Experis is currently supporting our globally-operating client within the biotech industry with their search for an experienced Senior CSV Engineer to support their operations at their manufacturing facility in the Solothurn region. This contract role will run a minimum of 6 months.

You are expected to have excellent knowledge of CSV Qualification and Life-cycle management activities in a highly integrated distributed process control system, MES, recipe driven operations and IT systems environment. You come with several years of experience dealing with industry-wide and regulatory expectations for computer system validation. You will be part of a team that collaborates with other internal stakeholders to ensure that CSV packages are consistent with validation plans and SOPs.

We are looking for a person with the following background:

• University education (Bachelor's Degree minimum) in Engineering/Sciences
• Minimum 10+ years of related hands-on experience
• Ability to work autonomously
• Excellent knowledge and background understanding of regulations governing computer systems and control including: FDA's 21 CFR Part 11, EMA's Annex 11, and MHRA's data integrity guidance
• Solid background and experience dealing with modern and risk based validation executions
• You must have a background within Lifesciences and/or Pharma/Biotech
• Direct experience with IT and MFG automation systems supporting GMP manufacturing
• You must hold either a Swiss or an EU passport to be considered for this position.
• Fluent English, any other languages are not a prerequisite

If you are immediately available for this exciting project in the Solothurn region, please get in touch directly with Eric Schuster (+41 44 229 9937) or send him your CV and testimonials today through the link in the advert. We can only consider Swiss/EU nationals for this engagement.

Experis is Europe's leading IT&T recruitment agency. Take a look at our homepage for other interesting opportunities or call us on +41 44 229 99 99. Experis has more than 200 currently open vacancies and we will be more than happy to find the perfect role for you! Just visit us www.experis.ch.