Senior Process Expert Aseptic Manufacturing Parenterals , Visp everyone
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Job Location:
Visp - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
About Us
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 tomorrows medicines. We support our clients in developing differentiated stable usable and safe injectable treatments for patients.
Your mission
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
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)
- 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
- 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
- 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
- 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)
- 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
Your profile
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.
Why us
We offer a dynamic environment where you can contribute meaningfully collaborate with exceptional minds and unlock your full potential.
Heres what sets ten23 apart:
Heres 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
Contact
For more information and clarification please connect with Amrith () from our Talent team!
About us
While most applicants fall short of 100% qualifications we embrace diverse perspectives and encourage applications from all qualified candidates regardless of background. Women & underrepresented groups we see you!
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23 Experience:
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23 Experience:
Senior IC
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About Company
The partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines.
