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.
1. Production Process Ownership

• Subject matter expertise in aseptic manufacturing processes (e.g., filtration, filling, sterilization, VHP)
• Ensuring robust, validated, and regulatory-compliant processes
• Evaluation and optimization of process parameters, equipment, technologies, and workflows
• Supporting the transfer of new products and processes into manufacturing (Tech Transfer)

2. Deviation, CAPA, and Change Control Management

• Independent investigation of complex deviations in the aseptic environment
• Conducting thorough root cause analyses (5-Why, Ishikawa, FMEA)
• Initiating, defining, and tracking sustainable CAPAs
• Technical evaluation and execution of process-related changes

3. Shopfloor Presence & Production Support

• Supporting teams in the aseptic production environment (“Gemba/Shopfloor”)
• Troubleshooting technical and process-related issues during operations
• Coaching personnel on process and aseptic best practices
• Ensuring all relevant process steps are performed in compliance with GMP

4. Qualification, Validation & Process Documentation

• Supporting and reviewing equipment, room, and system qualifications
• Preparation and review of validation protocols and reports (process validation, cleaning validation)
• Technical writing and review of reports, assessments, risk analyses, manufacturing records, batch protocols and SOPs
• Supporting media-fill studies and aseptic process simulations

5. Process Monitoring & Data Analytics

• Conducting trend analyses, process monitoring, and statistical evaluations
• Interpretation of critical process parameters (CPPs) and critical quality attributes (CQAs)
• Preparing regular process reports and providing input for PQR/APR
• Early identification of risks based on data analysis (process risks, deviation trends)

6. Audit & Inspection Support

• Technical point of contact for internal and external audits as well as regulatory inspections
• Ensuring the availability of audit-ready documentation
• Representing complex process topics and 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!