Process Engineer (m/f/d) - Downstream Processing and/or Upstream Processing / Biopharmaceutical / Large Molecules Drug Substance / GMP / Quality Risk Management (QRM) / German / English
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 (standby) 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, preparing, moderating, conducting, summarizing, reviewing, and updating 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.:
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
If this position has sparked your interest, please send us your complete application. If this position isn't quite the right fit and you'd prefer to be notified about other opportunities, you can also submit your application via this advertisement or to jobs[at]itcag[dot]com.
For more information about our company, our open positions, or our attractive payroll-only program, please contact us at
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with branches in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the IT, Life Science & Engineering sectors.
We offer both temporary staffing and payroll services. These services are free for our candidates, and we do not charge any additional fees for payroll.
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