Make a lasting impact for patients
We are seeking a highly organized and detail-oriented specialist to join our qualification team. As a CSV & Automation Qualification Specialist, you will manage automation and computerized system qualification in compliance with regulatory procedures.
About the role
You will define global qualification strategies and risk assessments, write qualification plans, protocols, and reports. You will also ensure the correct qualification of GMP installations and maintain qualification activity planning.
Key responsibilities
* Define and lead global qualification strategies and risk assessments
* Write qualification plans, protocols, and reports
* Ensure the correct qualification of GMP installations (automation, software, logic controllers, utilities)
* Maintain qualification activity planning and coordinate with external partners
Requirements
* In-depth knowledge of cGMP regulations and biotech/pharmaceutical manufacturing processes
* Excellent understanding of Automation systems and software structure, components, and communication links between technological layers
* Minimum 3 years' experience in pharmaceutical manufacturing and system qualification
* Expertise in computerized system validation and automation systems PLC/SCADA/DCS/MES
* Proficiency in English, both spoken and written, and additional language skills a plus
* Strong communication, organizational, and problem-solving skills
* Ability to work autonomously with excellent stress management
What we offer
A supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet.