MSAT Bioconjugates Cleaning Validation Expert(m/w/x)

Beschreibung

You will drive the cleaning validation strategy by blending scientific expertise with hands-on technical support to ensure regulatory compliance and seamless manufacturing operations.

Anforderungen

• •Master or PhD in bioconjugation, biotechnology, chemical engineering, organic chemistry or life science discipline
• •Preferred industrial experience in GMP environment (>3 years) in bioconjugation, biopharma manufacturing, BioConjugates or DSP
• •Advantageous experience in cleaning validation and with regulatory agencies
• •Excellent communication skills
• •Proficiency in English and advantageous knowledge of German
• •Motivation, creativity, agility and open-mindedness
• •Strong team orientation and solution-oriented working
• •Eagerness to foster teamwork and inclusion

Aufgaben

• •Define and design the site's cleaning validation strategy
• •Ensure scientific robustness and regulatory compliance
• •Collaborate with QA and Operations on asset improvements
• •Lead cleaning validation campaign preparations
• •Author protocols and review FMEAs and QC studies
• •Assess deviations and investigations during campaign execution
• •Evaluate data against defined acceptance criteria
• •Manage all cleaning validation documentation and SOPs
• •Maintain the facility and product validation matrix
• •Monitor and implement evolving regulatory requirements
• •Respond to health authority questions during inspections
• •Support batch release and define corrective actions

Tools & Technologien

Benefits