We are seeking a dedicated and experienced CSV Engineer to join our dynamic team. This role is integral to our Technical Services department, playing a key role in ensuring the validation phases of our projects are executed according to global and local policies, as well as legal and regulatory requirements.

In this role, you will be responsible for leading CSV packages, planning, coordinating, and executing all phases of computer system validation, and ensuring the validity of our computerized systems. This is an opportunity to make a significant impact in a fast-paced, innovative environment.

If you are looking for a challenging and rewarding role where you can make a real difference, we would love to hear from you.

Responsibilities

As a CSV Engineer, your primary responsibilities will include:

• Leading the CSV package(s) on assigned projects, taking accountability for the work produced by yourself and your colleagues.
• Planning, coordinating and executing all phases of computer system validation for production and QC Lab systems.
• Performing CSV periodic reviews of equipment and systems.
• Preparing, reviewing, and approving technical and GMP related documentation.
• Coordinating and executing FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners.
• Overseeing external subcontractors/software suppliers when required.
• Managing operational handling of Change Controls, CAPAs and Non-Conformances related to CSV.
  
  

Requirements

• 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.
• 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.
• Excellent communication skills.
• Business fluency in English. The German language is a plus.
  
  

Thank you for your application :)