CSV Engineer (5530-ADA)

 

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a CSV Engineer for a contract-position till end of 2024 (with high possibility for extension) based in Bern, Switzerland.

 

Main Responsibilities:

·      In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that:

o  Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities

o  Validation Master plans are up to date and established for all ongoing projects

·      Assess and lead the CSV package(s) on an assigned project

·      Taking accountability for the work to be produced by yourself and other colleagues that are under the assigned packages lead by this position

·      Hands on: Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, Validation Reports

·      Perform CSV periodic review of equipment and systems

·      Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)

·      Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards

·      Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners

·      Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups

·      Coordination and oversight of external subcontractors / software suppliers when required

·      Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV

·      Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems are assessed and resolved

 

Qualifications and Experience:

  •  Relevant working/residency permit or Swiss/EU-Citizenship required
  • Bachelor/master’s degree in technical or natural sciences
  • A minimum of 3 years of working experience within pharma or a biotech company
  • Experience on validating computerized manufacturing equipment (CSV context)
  • Experience on validating software & hardware infrastructure (e-g: servers, network and software services)
  • A minimum of 4 years of working experience with CSV
  • Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
  • Business fluency in English preferred
  •  German language advantageous
  •  Experience on validating complex computerized analytical equipment (QC Laboratory equipment)
  • Basic know-how of Validation requirements according to cGMP regulations
  • Basic know-how of quality assurance principles

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