Ten23-health·6 days ago
6 days ago
Process Expert Sterile Production - Visp (Maternity Cover) e/v/e/r/y/o/n/e
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What you'll do
- 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.
What they're looking for
- 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.
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Ten23-health
Visp, Switzerland
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