Job Description

Project:

For our client, a large pharmaceutical company based in Basel, we are looking for a highly qualified Process Engineer (m/f/d)

Background:

As a Process Engineer in Manufacturing, you will deliver solutions for the USP, DSP, or ADC areas at Basel Drug Substance Manufacturing to ensure safe and high-quality production. You will benefit 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 Roche production sites.

The ideal candidate will have a university degree and at least three years of professional experience, along with extensive knowledge of downstream and/or upstream processing of biotechnologically manufactured products. Furthermore, 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 as 1st and 2nd level manufacturing support Planning and coordination of troubleshooting activities and root cause analysis in close collaboration 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, preparation, moderation, execution, summarization, review, and updating of new and existing quality risk assessments within the context of commercial manufacturing to ensure the systematic identification and reduction/elimination of GMP compliance risks Owner of the production processes (Interface between Manufacturing, Science and Technology (MSAT)) Creation and presentation of 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 and/or upstream processing of biotechnologically manufactured products Minimum 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 using steel or single-use technology is advantageous Experience with technical transfers and quality risk management (QRM) is advantageous Team player with a very high degree of independence in a self-directed environment Excellent communication skills for interaction within the team, at local and global interfaces Enjoyment of working in global teams
The local working language is German; therefore, very good German language skills and written communication skills are required Excellent written and spoken German and English skills

Reference No.: 924625

Role: Process Engineer

Industry: Pharmaceuticals

Location: Basel

Workload: 100%

Start: ASAP (Latest possible start date: February 1, 2026)

Duration: 9 months

Application deadline: December 10, 2025

Job Type: 100%

Work Location: On the road