Process Engineer (m/w/d)
We are seeking a motivated Process Engineer for a temporary assignment of one year with potential extension at our client, F. Hoffmann‑La Roche Ltd., based in Basel. The role is with Work Selection AG.
Responsibilities
* Technical and scientific support (1st and 2nd line support) to ensure robust and efficient manufacturing processes in a GMP environment.
* On‑call (Pikett) duty as first and second‑level Manufacturing Support.
* Planning and coordinating troubleshooting activities and root cause analysis in close collaboration with Manufacturing Value Streams, Quality and Support units.
* Handling planned and unplanned events in accordance with GMP guidelines.
* Review and approval of electronic batch records for commercial and clinical products (MES‑based Batch Record Review).
* Act in accordance with internal quality system requirements and cGMP regulations of health authorities.
* Lead or support optimization projects and introduction of new technologies.
* Represent the site in network initiatives and network communities.
* Plan, prepare, moderate, conduct, summarize, review and update new and existing quality risk assessments in the framework of commercial manufacturing to ensure systematic identification and reduction/elimination of GMP‑compliance risks.
* Owner of production processes (interface between Manufacturing, Science and Technology (MSAT) areas).
* Create and present concepts, documents and assessments for GMP audits and regulatory inspections.
Requirements
* Completed university degree in natural or engineering sciences, or a degree in biotechnology or bioprocess engineering preferred.
* 3–5 years of experience and extensive knowledge in Downstream Processing and/or Upstream Processing of biotechnological products.
* At least 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 stainless steel or single‑use technology advantageous.
* Experience in technical transfers and quality risk management (QRM) advantageous.
* Team player with a high degree of independence in a self‑directed environment.
* Excellent communication skills in team interaction, local and global interfaces.
* Enjoy working in global teams.
* Local working language German – excellent German language and writing skills required.
* Excellent German and English skills in spoken and written.
Benefits
* Access to attractive fitness and swimming pool facilities or the gaming‑room as a creative retreat.
* Enjoy a range of high‑quality foods in modern company restaurants.
* Parking available on site under a sustainable mobility concept for qualified candidates.
* Professional onboarding and a thorough introduction to your new role during Welcome Days.
* Financial support for your professional development plans.
* Attractive discounts at major retailers and 200+ top brands throughout the year.
* Fleet discounts for new vehicle purchases and ongoing fuel discounts with our fuel card.
We value diversity and welcome applications from all individuals regardless of gender, social origin, religion, age, and identity. We use only one gender form for simplicity; all gender forms are understood to be equally intended in each context.
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