MSAT DP Sterile Process Lead

We are looking for an MSAT DP Sterile Process Engineer to join our Internal & External Manufacturing Large Molecules MSAT, based in our office in Braine-l’Alleud, Belgium.

As an MSAT DP Sterile Process Engineer, you will be responsible for managing technology transfers and optimizing processes for sterile drug products. You will work closely with various teams to ensure regulatory compliance, improve product quality, and optimize production costs.

Responsibilities

• Apply the company's health and safety policy and ensure compliance with applicable legislation.
• Lead the technology transfer with strong governance, coordinating technical, QA, QC, RA, analytical methods transfer, supply, and affiliate management aspects.
• Manage projects by adhering to budget, timelines, and risk mitigation plans, and report progress to the Head of DP Sterile MSAT.
• Identify and implement process improvements to enhance quality, reduce cycle times, and lower production costs.
• Ensure manufacturing processes comply with regulatory requirements and industry standards.
• Collaborate with the quality assurance team to ensure product quality and consistency and lead critical investigations into process deviations.

Qualifications

• Master’s degree in engineering, Pharmaceutical Sciences, or a related field.
• Minimum of 5 years of experience in pharmaceutical manufacturing processes.
• Technical and industrial expertise in sterile pharmaceutical products.
• Experience in managing technology transfers.
• Experience with regulatory submissions and compliance in a GMP environment.
• Experience in project management.
• Financial understanding of the impact of Opex, Capex, and COGS drivers.
• Fluent in English (written and spoken).