Job Description
Our state-of-the-art facility in Schachen enables and advances our best work by integrating leading-edge technology with a dynamic, activity-based workspace. This supports seamless connection and collaboration within and across teams and functions, providing Biologics Drug Substance manufacturing for Clinical Supply.
The Schachen site serves as a magnet that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel they belong to the site, which is shaped by them.
Qualification and Computer System Validation Senior Specialist Role
As a Qualification and Computer System Validation (CSV) Senior Specialist, you will be part of the Technology Lifecycle Excellence (TLE) Team. Your role involves ensuring the qualification of equipment and computer systems in compliance with regulatory requirements.
Your responsibilities are critical in maintaining permanent inspection readiness while optimizing processes for efficiency and compliance. You will act as an SME (Subject Matter Expert), lead small projects, and contribute to the continuous improvement of qualification and validation strategies at the site.
* Ensure compliance with regulatory requirements for Clean Air Systems (e.g., HVAC, isolators, LFHs) and computerized systems.
* Optimize qualification and validation processes, standardizing documentation for efficiency and compliance.
* Serve as the primary point of contact and SME for qualification and CSV, providing expert guidance to internal and external stakeholders.
* Lead small-scale qualification and CSV projects with a hands-on, results-driven approach.
* Mentor and train less experienced colleagues to strengthen expertise in qualification and validation.
* Ensure audit and inspection readiness, actively representing the qualification and CSV domain during regulatory inspections.
* Support root cause investigations and drive process improvements in response to deviations.
Your Profile
Required Qualifications:
* Bachelor's degree (or higher) in Engineering, Life Sciences, Chemistry, or a related field.
* Minimum 7 years of experience in the pharmaceutical industry, including at least 5 years in Equipment Qualification and CSV.
* Strong expertise in Clean Air Systems (HVAC, isolators, LFHs).
* Extensive experience in auditing and compliance within the pharmaceutical sector.
* Excellent communication skills in English and German – ability to convey complex technical topics in a clear and engaging manner.
* Strong project management skills – ability to organize, prioritize, and deliver projects efficiently, utilizing relevant project management tools.
Preferred Qualifications:
* Experience with Quality Change Management Systems.
* Expertise in Root Cause Analysis and Deviation Management.
Why Join Our Team in Schachen?
This role offers the opportunity to work in a highly advanced facility, collaborating with an experienced team and contributing to the evolution of qualification and validation processes. If you are looking for a challenging and impactful position, we would love to hear from you.