Process Engineer

BioTalent; Schaffhausen; On-site; CHF 120,000 - 180,000; Full time

Job summary

BioTalent is seeking a Process Engineer (m/f) to join the Drug Product Development & Delivery Process Innovation team. You will develop, optimize, and scale biologics fill & finish processes while driving innovation and regulatory support across multifunctional teams.

The role requires extensive process engineering experience in pharma/biopharma, tech transfer, and familiarity with PAT tools (Raman, FlowVPX, flow sensors). English communication is essential for global collaboration.

Qualifications

• Bachelor's degree with 9+ years or Master's with 6+ years in a relevant field.
• Strong process engineering experience in pharma/biopharma.
• Proven tech transfer and scale-up knowledge.
• Biologics and sterile fill & finish manufacturing familiarity.
• Experience with PAT tools and analytical technologies.

Responsibilities

• Lead process development and engineering for biologics fill & finish.
• Act as innovation lead for new technologies and improvements.
• Design/execute lab studies to support development.
• Develop scale-down models to evaluate process parameters.
• Troubleshoot process performance using scientific methods.
• Support tech transfer from development to manufacturing.
• Prepare regulatory dossiers and documentation.
• Collaborate with global cross-functional teams to drive improvement.

Skills

Process engineering

Biopharmaceuticals

Scale-up

Technology transfer

Regulatory documentation

English communication

Education

Bachelor's degree +9+ years

Master's degree +6+ years

Tools

Raman spectroscopy

FlowVPX

Flow sensors

Job description

Process Engineer (m/f) - Fill & Finish Process Innovation

Summary

We are seeking an experienced Process Engineer to join the Drug Product Development & Delivery (DPD&D) Process Innovation team. This role focuses on the development, optimization, and scale-up of fill & finish processes for biologics, while driving innovation and supporting regulatory and technical development activities across multifunctional teams.

Responsibilities

• Lead process development and engineering activities for biologics fill & finish operations.
• Act as innovation lead for projects, identifying and implementing new technologies and process improvements.
• Design, execute, or oversee laboratory studies supporting process development initiatives.
• Develop and apply scale-down models to evaluate critical process parameters and support scale-up activities.
• Investigate and troubleshoot process performance issues using scientific and engineering principles.
• Support technology transfer activities from development to manufacturing.
• Prepare and contribute to regulatory submissions, dossiers, and technical documentation related to fill & finish processes.
• Collaborate with development, manufacturing, and supply chain teams to analyze process data and drive continuous improvement.

Must-Haves

• Bachelor's degree with 9+ years of experience or Master's degree with 6+ years of experience in a relevant scientific or engineering field.
• Strong experience in process engineering within the pharmaceutical or biopharmaceutical industry.
• Proven experience supporting technology transfer and process scale-up activities.
• Knowledge of biologics and sterile fill & finish manufacturing processes.
• Experience with freeze/thaw, mixing, filtration, and filling operations.
• Understanding of Process Analytical Technology (PAT), including tools such as Raman spectroscopy, FlowVPX, or flow sensors.
• Experience troubleshooting manufacturing and process performance issues.
• Excellent communication skills in English and ability to work within cross-functional global teams.