Qualification Engineer (m/w/d) In Basel Biotech Drug Substance Manufacturing

Join Roche

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The Position

The Basel Biologics Drug Substance Manufacturing Organisation is responsible for the production of commercial biotech APIs (Active Pharmaceutical Ingredients, e.g. Avastin and Tecentriq) in modern and highly automated facilities. The group HVAC & Cleanroom Qualification is responsible for zone and room qualification concepts, as well as their implementation. It understands itself as a service organization for the manufacturing units.

The Opportunity

Your main tasks include:

• Management, coordination and execution of HVAC qualification projects, temperature mappings, approval of qualification plans and reports in eVal Roche
• Creation of qualification strategies, risk analyses, (re-)qualification plans and reports
• Processing of changes, deviations, CAPAs, and creation of technical assessments for stakeholders
• Development and implementation of improvement suggestions for HVAC qualification concepts
• Representation of these qualification topics during authority inspections as well as in local and global networks, task forces, and project teams
• Collaboration with partners from site engineering, IT, manufacturing units, and compliance departments and other internal interfaces
• Working in an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation to achieve the operational goals
• Active participation in measurements in the course of (re-)qualification activities and troubleshooting related

Who You Are

For this exciting challenge, you bring the following qualifications:

• Proven experience in the GMP-relevant environment for the pharmaceutical industry. You are also familiar with the operation and qualification/validation of pharmaceutical production facilities and systems
• Bachelor’s, Master’s or comparable higher degree in natural sciences, engineering, biotechnology or similar discipline is advantageous
• Professional experience in the pharmaceutical industry in a production, development, or quality function
• Experience with room qualifications and temperature mapping is advantageous
• Knowledge in the area of HVAC and air distribution systems
• Fluent spoken and written German and English
• You are flexible and ready to work outside of normal working hours if necessary

Your application

Please upload your complete application documents. This includes your resume, relevant certificates and diplomas (academic and professional) as well as your cover letter, in which you highlight your motivation and suitability for this position. We look forward to your application!