Process Expert Sterile Production - Visp (Maternity Cover) e/v/e/r/y/o/n/e

ten23 health; Lavamünd; Hybrid; EUR 80.000 - 110.000; Vollzeit

Benefits dieser Stelle

Flexible working arrangements

Open culture

Training opportunities

Competitive pension plan

Annual bonus

Zusammenfassung

ten23 health is seeking a Process Expert to lead aseptic manufacturing process optimization for sterile parenteral products. You will support transfer of new products, investigate deviations, and ensure robust GMP-compliant operations on the shop floor.

You will collaborate with Production and Quality Assurance, develop risk assessments, SOPs, and validation protocols, and provide technical leadership in audits. German and English fluency are essential.

Qualifikationen

• University degree in Pharmacy or related technical field.
• 5+ years of experience in sterile pharmaceutical manufacturing.
• Strong knowledge of aseptic manufacturing, fill-finish, and lyophilization.
• Experience with EU-GMP Annex 1, FDA 21 CFR 210/211, ISO cleanroom standards.
• Proven skills in root-cause analysis, CAPA, and data-driven decision making.
• Excellent German and English communication, able to guide cross-functional teams.

Aufgaben

• Provide process & compliance support, optimization, and continuous improvement of sterile manufacturing processes.
• Oversee transfer of new products and processes into manufacturing.
• Investigate deviations with structured root cause analyses and track CAPAs.
• Troubleshoot on the shop floor and coach production on GMP practices.
• Author and maintain risk assessments, SOPs, and manufacturing records.
• Support equipment, cleanroom, and system qualifications, and oversee validation protocols.
• Perform statistical evaluations of CPPs/CQAs to identify risks and inform PQR/APR.
• Act as technical representative during audits, ensuring audit-ready documentation.

Kenntnisse

Aseptic manufacturing

Fill-finish technology

Lyophilization

Process validation

Statistical data analysis

German and English communication

GMP compliance

Root-cause analysis

Ausbildung

University degree in Pharmacy

Related technical/natural science degree

Jobbeschreibung

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 tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.

Your mission

Visp I Full-time | Start 1st Jan 2027 until 31st August 2027

As the 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.

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.

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.

Contact

For more information and clarification, please connect Amrith ([e-mail]) from our Talent team!