Qualification Engineer (m/f/d) Room Monitoring & Qualification

Generation of Experts

agap2 is a strong community of engineers, pharmacists, and scientists. We help our clients successfully execute complex projects – from plant commissioning and process optimization to quality management projects.

Teamwork instead of elbows

We always work as a team. Highly ambitious, with a lot of appreciation and even more humanity, we ensure satisfied customers and motivated employees. agap2 offers you real variety in your job and professional perspectives with steep learning curves.

Tasks

• You adapt qualification-relevant risk analyses (RA) based on existing documentation and change structures and professionally bring them to finalization
• You also independently revise and finalize the associated qualification plans
• You carry out qualification-relevant tests according to the validation matrix and precisely document the results
• You reliably process the corresponding reports up to finalization and release
• You independently conduct temperature distribution studies as part of OQ and PQ
• You work on qualification-relevant topics related to monitoring, alarm management, and SCADA systems within the scope of the agreed service
• You document all your work in a GMP-compliant manner within the specified documentation and system structures

Qualification

• A completed degree in engineering or natural sciences (e.g., process engineering, pharmaceutical technology, or comparable) forms your professional basis
• You have relevant professional experience in qualification and validation (DQ/IQ/OQ/PQ) in a GMP-regulated environment
• You are familiar with handling risk analyses as well as creating and processing qualification documents
• Experience with monitoring and SCADA systems, and ideally with temperature distribution studies, rounds off your technical profile
• Careful, structured working methods and sound GMP knowledge characterize you
• Good German and English language skills round off your profile

Benefits

• Permanent employment contract 🔓
• Fair salaries including an annual salary increase 💰
• Team events such as regular meetups, summer parties, and Christmas parties, company runs 🎉
• Further benefits: Opportunities for professional development, company pension scheme, employee discounts, health offer EGYM Wellpass 🎁
• Good work-life balance and a working time account ⚖️
• Steep career development through project responsibility in diverse areas 📈
• Individual support during project phases and beyond through dedicated internal contact persons 🤝
• A diverse team with a relaxed atmosphere and plenty of room for learning and personal development 👥

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