As the Senior Process Expert you are responsible for the process & compliance support, optimization, and continuous improvement of processes used in the manufacturing of sterile parenteral products. This role includes operational oversight of aseptic production steps as well as the scientific and technical evaluation of process data, changes, and deviations. The position holder is a recognized subject matter expert in aseptic manufacturing, supporting Production and Quality Assurance and ensuring robust, compliant, and efficient manufacturing processes.
 
Your responsibilities will include:

• Serve as the subject matter expert for aseptic manufacturing processes (e.g., filtration, filling, sterilization, VHP), continuously evaluating and optimizing parameters, equipment, and workflows.
• Provide scientific and technical support for the seamless transfer of new products and processes into manufacturing.
• Independently investigate complex deviations in the aseptic environment using structured root cause analyses to define and track sustainable CAPAs.
• Actively troubleshoot technical issues directly on the shopfloor while coaching production personnel on aseptic best practices and strict GMP compliance.
• Author, review, and maintain critical process documentation, including risk assessments, SOPs, manufacturing records, and the technical evaluation of process-related changes.
• Support equipment, cleanroom, and system qualifications, and actively oversee validation protocols, including media-fill studies and aseptic process simulations.
• Conduct statistical evaluations and trend analyses of critical process parameters (CPPs) and quality attributes (CQAs) to proactively identify risks and provide input for PQR/APR.
• Act as the primary technical representative during internal and external audits, ensuring documentation is audit-ready and clearly presenting complex technical rationales to inspectors.

We are looking for someone with:

• University degree in Pharmacy, Biotechnology, Chemistry, Process or Mechanical Engineering, or a related technical/natural science.
• At least 5+ years of professional experience in sterile pharmaceutical manufacturing, with deep technical knowledge of fill-finish technology, filtration, and lyophilization.
• In-depth understanding of EU-GMP Annex 1, FDA 21 CFR 210/211, and ISO cleanroom standards, including proven experience representing technical topics during inspections and customer audits.
• Strong experience in aseptic techniques, validation, and qualification, supported by a command of statistical methods and modern data analysis tools.
• Highly structured thinker with a strong technical affinity, capable of conducting root-cause analyses and making independent, data-driven decisions.
• Excellent communication skills in German and English, with the ability to translate complex technical concepts into clear, actionable guidance for cross-functional teams.
• A resilient and responsible professional who balances a team-oriented approach with a high-quality mindset to ensure robust and compliant manufacturing processes.

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.

For more information and clarification, please connect with Amrith (amrith.kiran@ten23.health) from our Talent team!