process engineer (upstream or downstream).

General Information:

• Start Date: ASAP
• Latest Possible Start Date: February 1, 2026
• Planned Employment Duration: September 30, 2026
• Extension: unlikely
• Workplace: Basel
• Workload: 100%
• Home Office: possible by arrangement, on-site required
• Team: 15-25 team members
• Department: Drug Substance Internal and External Manufacturing (MMN)
• Working Hours: Standard

About the job:

As a Process Engineer in Manufacturing, you will provide solutions for the USP, DSP, or ADC areas at Basel Drug Substance Manufacturing for safe and high-quality production. They will serve both our patients and our employees in the Manufacturing Unit by developing and implementing process improvements, fostering dialogue and collaboration between global functions in Development, Innovation, and Regulatory, and exchanging information with other production sites.

Your Profile:

• University degree and at least 3 years of professional experience, along with extensive knowledge of downstream and/or upstream processing of biotechnologically manufactured products.
• At least two years of experience in biopharmaceutical manufacturing or development are required, as well as experience working in a cGMP environment.

Tasks & responsibilities:

• Technical and scientific support (1st and 2nd line support) to ensure robust and efficient manufacturing processes in a GMP environment
• On-call duty (standby) as 1st and 2nd level manufacturing support
• Planning and coordination of troubleshooting activities and root cause analysis in close cooperation with the manufacturing value streams, quality and support units
• Handling planned and unplanned events according to GMP guidelines
• Review and approval of electronic batch records for commercial and clinical products (MES-based batch record review)
• Acting in accordance with the requirements of the internal quality system and the cGMP regulations of the health authorities
• Leading or supporting optimization projects and the introduction of new technologies
• Representing the site in network initiatives and network communities
• Planning, preparing, moderating, conducting, summarizing, reviewing, and updating new and existing quality risk assessments in commercial manufacturing to ensure the systematic identification and reduction/elimination of GMP compliance risks
• Owner of production processes (interface between Manufacturing, Science and Technology (MSAT))
• Creating and presenting concepts, documents, and assessments during GMP audits and regulatory inspections

Must Haves:

• Completed degree in natural sciences or engineering, or preferably a degree in biotechnology or bioprocess engineering
• Minimum 3-5 years of experience and correspondingly extensive knowledge in downstream processing and/or Upstream Processing of Biotechnologically Manufactured Products
• Min. 2 years of experience in biopharmaceutical manufacturing or development
• Experience working in a cGMP environment
• Hands-on experience in large molecule drug substance manufacturing processes in steel or single-use technology is an advantage
• Experience with technical transfers and quality risk management (QRM) is an advantage
• Team player with a very high degree of independence in a self-directed environment
• Excellent communication skills when interacting within the team, with local and global interfaces
• Enjoyment of working in global teams
• The local working language is German, therefore very good German skills and writing skills are required
• Excellent German and English skills, both written and spoken.

Sounds interesting? Apply Now! We look forward to receiving your application.

Application Submission Deadline: 10.12.2025