Process Expert Hygiene (d/f/m) 80-100%

ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.As a Process Expert Hygiene, you will play a critical role in ensuring the highest levels of hygiene and safety within our aseptic manufacturing environment. You will be responsible for developing, implementing, and monitoring hygiene standards and procedures to safeguard product quality and employee safety. This position requires a strong understanding of Good Manufacturing Practices (GMP) and a commitment to continuous improvement.Your responsibilities will include:

• Develop, implement, and continuously improve hygiene concepts for aseptic production areas, including cleanrooms and storage facilities.
• Ensure compliance with all relevant hygiene regulations, including GMP and GLP guidelines.
• Conduct regular hygiene checks, audits, and environmental monitoring to identify and address any potential deviations.
• Train and educate employees on:
• Cleaning, disinfection, and decontamination procedures.
• Proper cleanroom behavior and aseptic work practices.
• Correct gowning techniques.
• Manage and coordinate cleaning activities, including:
• Validation of cleaning and room decontamination processes (e.g., VHP).
• Selection and evaluation of cleaning agents.
• Oversee change and deviation management for cleanrooms and hygiene-related procedures.
• Coordinate with external cleaning staff to ensure efficient and effective cleaning services.
• Analyze environmental monitoring data in collaboration with Quality Control to identify root causes of deviations and implement corrective actions.
• Maintain accurate and up-to-date hygiene documentation, including cleaning protocols, test reports, and audit records.
• Collaborate with other departments (e.g., Quality Control, MSAT, Maintenance) to continuously improve hygiene standards.
• Support the preparation and execution of internal and external audits (e.g., GMP audits), including the implementation of corrective actions.

We are looking for someone with:

• Degree in pharmacy, food technology, microbiology, biotechnology or a similar specialisation or comparable professional experience.
• Several years of experience in hygiene or quality assurance, ideally in the pharmaceutical industry or a highly regulated sector.
• Sound knowledge of GMP guidelines and hygiene standards as well as the application of cleaning and disinfection methods.
• Experience in conducting hygiene controls and audits.
• Very good analytical skills and a structured way of working.
• Strong communication skills and team-orientation.
• Independent, responsible and solution-orientated way of working.
• Very good written and spoken German and English.

We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
 
Here's what sets ten23 apart:

• A valuable and impactful career development opportunity in an inspiring environment  
• Flexible working arrangements and environment with an open culture and diverse workforce  
• The opportunity to work with and learn from highly qualified and experienced employees  
• Our learning and self-developing culture offers a wide range of training options  
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit 

At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.Click on Apply Now! 

For more information and clarification, please connect Amrith ([email protected]) from our Talent team!