Technical Services & Validation Specialist

Short Job Description/Responsibilities:

• Recombinant therapeutic protein process scale-up, technology transfer and process validation
• Process improvements and optimization at laboratory and manufacturing scale facilities, support of investigations in manufacturing (problem solving)
• Scientific and technical support for recombinant therapeutic protein and plasmid DNA commercial manufacturing
• Preparation of registration documentation and collaboration with regulatory agencies
• Collaboration with different corporation departments involved in projects
• Work in lab scale and manufacturing scale facility

• University Degree or 300 ECTS - Biotechnology, Food Technology, Natural Sciences, Chemical Engineering and Technology
• Knowledge of process engineering, molecular biology, biochemical engineering, protein biochemistry, protein purification, chemical technology
• Experience on same or similar positions in technology transfer and process validation in pharmaceutical industry
• Proficiency in Croatian and English language
• IT (MS Office: Word, Excel, PowerPoint)

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• Accountability and good communication skills
• Adaptable, proactive, systematic and punctuate
• Good time management abilities, advance problem-solving and research skills

• Experience on same or similar positions in biopharmaceutical industry
• Knowledge and experience in mathematical statistics and information technology (IT)
• Experience with cleaning strategy and cleaning validation
• Working understanding of regulatory requirements and GMP standards