CSV Automation Engineer

Job description

Do you have experience with GMP production? Knowledge of Computer System Validation? This is your chance to help protect the world against the Corona virus.

Our client is a worldwide well know pharmaceutical production company. Recently they have acquired a pharmaceutical production site in the Leverkusen area. At this moment the site is being rebuild in order to start the fill and finish of a COVID-19 vaccine.

In order to get ready for production it is important to make sure all new and existing equipment is configured for the new, mostly single use, production methods. The eequipment includes a Bosch filling line, autoclave and parts washers. As CSV Consultant your tasks will include:

  • Identifying data system boundaries
  • Performing compliance checks of systems to ensure 21CFRPart11 robustness.
  • Developing automation VMP and lifecycle documentation based on GAMP 5 and part 11 requirements.
  • Identifying automation integration system boundary, and familiar with of PLC, SCADA, DCS, Data Historian, reporting tool, OPC and servers.

It is a role with impact and from strategic importance in the modification process.

Job requirements

Does this sound like a project for you? Then please see if you are a match to the requirements:

  • Around 5 + years of experience in CSV in Biotech/Pharma manufacturing environment.
  • Well versed in control system validations for PCS, SCADA and EMS.
  • Knowledge on E2500, V Model concept along with GAMP5 and S88.
  • Familiar with Aseptic Filling & Lyo system is plus
  • Knowledge on industry guidelines and international regulation for GMP regulated environments
  • Fluent in English with good communication skills, German is a plus

Are you available at short notice? You will start with a six-month contract with the option to extend. This position is open to both contractors and employees.

Interested and a (close) match? Apply now, if we also believe you are a match, we will be in touch within two working days.