Bioprocess Engineer USP/DSP( Microbial)/BioConjugates(m/w/x)

Anforderungen

• Master's degree or equivalent in Biotechnology, Biochemical Engineering, Biochemistry, Process Engineering, or related Life Science, or Bachelor's with pharmaceutical production experience
• Expertise in Upstream, Downstream processing, or Bio-conjugation technology
• Experience in bio-manufacturing and/or biopharmaceutical facility scaling up, with advantageous cGMP experience
• Excellent English communication skills
• German proficiency (plus)
• Organized and goal-oriented approach
• Willingness to consider new ideas
• Strong motivation
• Problem-solving approach

Aufgaben

• Execute timely operational activities for clinical and commercial manufacturing
• Maintain safety and quality standards
• Apply subject matter expertise to new facility design
• Apply subject matter expertise to new facility commissioning
• Apply subject matter expertise to new facility qualification
• Apply subject matter expertise to operational preparation
• Apply subject matter expertise to operational execution
• Apply subject matter expertise to operational cleaning
• Apply subject matter expertise to operational changeovers
• Lead upstream processing operations
• Lead downstream processing operations
• Lead Bio-Conjugates operations
• Perform cGMP-compliant manufacturing tasks
• Execute batch manufacturing
• Evaluate test results
• Troubleshoot equipment and recommend resolutions
• Review production documentation
• Address deviations
• Address change requests
• Implement CAPAs
• Assist with automation recipe development for equipment
• Assist with automation recipe development for facility components
• Assist with automation recipe review for equipment
• Assist with automation recipe review for facility components
• Train production personnel on assigned products
• Participate in audits
• Participate in customer visits

Berufserfahrung

Ausbildung

Sprachen