Process Engineer – Downstream (Pharma)

About the role

We are seeking a Process Engineer (Downstream) to join the B91 Manufacturing Unit (Single‑Use Technology) at our Basel drug substance site. You will support safe, high‑quality antibody production and drive process improvements across development, innovation, and regulatory functions.

Key responsibilities

• Provide technical and scientific support to shift teams, ensuring robust GMP manufacturing.
• Plan and coordinate troubleshooting, root‑cause analyses, and event handling with Manufacturing Units, Quality, MSAT, and other departments.
• Review and approve electronic batch records for commercial and clinical products using MES.
• Lead or support optimization projects, new technology introductions, and process risk assessments.
• Act as owner of production processes, interfacing between Manufacturing, Science, and Technology.
• Prepare and present documentation during GMP audits and health‑authority inspections.
• Represent the site in network initiatives and communities.

Required profile

• University degree in Natural Sciences, Engineering, Biotechnology or Bioprocess Engineering.
• 3–5 years of experience in downstream processing (upstream knowledge is a plus).
• Minimum 2 years of experience in biopharmaceutical manufacturing or development within a cGMP environment.
• Proven ability to work in cross‑functional teams and follow internal Pharmaceutical Quality System requirements.

Required skills

• Downstream processing expertise.
• cGMP compliance and GMP‑guided event handling.
• MES‑based batch record review.
• Root‑cause analysis and troubleshooting.
• Quality Risk Assessment methodology.
• Process optimization and technology transfer.
• Single‑Use Technology (SUT) knowledge.

What we offer

• 12‑month fixed‑term contract with the possibility of extension.
• Hybrid work mode – remote work possible upon agreement, with required onsite presence.
• Opportunity to work in a leading global pharmaceutical company and contribute to innovative antibody production.