MSAT Principal Engineer:in

Aristo Group; Oberwallis; On-site; CHF 100,000 - 140,000; Full time

Job summary

Aristo Group in Visp, Switzerland seeks an experienced Process Expert for Ibex Solutions in mammalian manufacturing (up to 20,000 L). You will own scale-up, supervise transfers, and optimize processes across USP and DSP in Drug Substance.

You will lead cross-functional teams, coordinate tech transfers, interface with development and operations, ensure GMP compliance, and contribute to process validation and continuous improvement while mentoring staff and driving new ideas.

Qualifications

• Biotechnology or chemical engineering background required.
• 5+ years in biopharma manufacturing or process development.
• GMP knowledge and bioprocess technology understanding.
• Fluent in English.
• Strong leadership and communication across interfaces.
• Team-oriented and well-organized.
• Agile, proactive and able to drive ideas.

Responsibilities

• Lead cross-functional teams as a process expert for tech transfers, scale-up and on-time implementation at manufacturing scale.
• Interface between process development/donor and operations; ensure scalability and manufacturability.
• Apply formal processes and tools to manage transfer info, risk and change control during technology transfer.
• Work as MSAT process expert in capital investment projects for building and commissioning manufacturing units; provide process inputs (block-flow diagrams, media lists, critical parameters).
• Implement manufacturing processes in the plant and support campaign preparation, execution and closure with daily batch reporting.
• Compile process-related deviations, change requests and campaign reports for GMP records.
• Contribute to development and implementation of standardized MSAT procedures.
• Drive continuous improvement of process performance and mentor staff.

Skills

Leadership

Cross-functional

GMP knowledge

English fluency

Communication

Team orientation

Regulatory knowledge

Education

Biotech/Chemical Eng

Job description

The site in Visp, Switzerland is growing and for our Biologics organization, we are currently looking for experienced Process Experts in Ibex® Solutions, our recently launched unique biological manufacturing and development concept. We have opportunities in both USP and DSP in Drug Substance for mammalian large-scale manufacturing (up to 20.000L). As a process owner, you are responsible for the successful scale up, supervision and optimization of mammalian processes.

Your Responsibilities

• Leading cross functional teams as a process expert tasked with technology transfers (process design and up-scaling) and timely process implementation at manufacturing scale. This includes the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals.
• Act as the interface between the process donor (customer, process development) and operations. Responsible to ensure process scalability and manufacturability.
• Securing success during technology transfer by applying formal processes and tools to manage the transfer of information, process related risks and change control
• Working as MSAT process expert in Capital investment projects for building and commissioning of the manufacturing units. Main responsible for delivering all input required for the specific processes (block-flow diagrams, media and buffer lists, critical parameter lists)
• Responsible for implementing the manufacturing process in the plant.
• Interacting directly with customers during tech transfer, campaign preparation, execution and closure including daily reporting of batch status and performance.
• Ensuring timely compilation of process related deviations, change requests and campaign reports
• Compiling CMC sections in filing documents and technical content of validation reports
• Contributing to the development and implementation of standardized MSAT procedures and processes.
• Responsible for continuous improvement of process performance
• Supervising tasks in the area of local and global MSAT initiatives or leading major task forces or troubleshooting teams.
• Evaluating and driving innovative trends within the respective area of expertise
• Acting as a mentor for scientific and production staff in different fields of expertise.
• Performing process specific trainings for production staff.
• Responsible for the resolution of process issues that may arise during manufacturing, considering all regulatory requirements
• Responsible for execution of GMP risk analysis for the manufacturing processes.

Your profile

• Preferred area of study: Biotechnology, chemical engineering or related disciplines
• More than 5 years of experience in the area of biopharma manufacturing and / or process development preferable in the area of Mammalian Manufacturing
• GMP and deep understanding of bioprocess technology
• Fluency in English
• Strong leadership skills
• Very good communication skills and interaction with all kinds of interfaces within customers and the project organisation
• Strong team orientation
• Structured, focused and well-organized working attitude
• Open-minded for new ideas and suggestions
• Agile, highly motivated and dynamic drive