MS Process Engineer (Fill and Finish) (m/w/d)

Primary Responsibilities

• Lead process improvement projects and optimize process parameters.
• Ensure process performance using Quality by Design (QbD) and Continuous Process Verification (CPV).
• Address deviations, CAPAs, and conduct product impact assessments.
• Oversee FF process/equipment projects from URS to PPQ.
• Support validation activities and technology transfer.
• Prepare for and participate in regulatory inspections.

• 45% Manufacturing Support: Monitor processes, manage deviations, and ensure compliance.
• 45% Projects: Lead or contribute to FF process improvement and equipment initiatives.
• 10% Regulatory: Address audit and inspection-related tasks.

Qualifications

• Education: Degree in biotechnology or engineering.
• Experience: 3–5 years in FF processes for recombinant protein; cGMP knowledge.
• Languages: Fluent in English and French.
• Skills: Strong statistical analysis, communication, and leadership abilities.