MSAT Process Engineer

MSAT – (Senior) Process Engineer Small Molecule Drug Substance

The chemical production facility in Geel is the largest manufacturer of active pharmaceutical ingredients (APIs) and spray dried powders (SDP) within the network and our API Launch and Grow site. The APIs/SDPs we manufacture are sent for further processing through pharmaceutical production into tablets, ointments, syrups, and other formulations, which are distributed to our patients around the globe.

The (Senior) Process Engineer will become a member of the MSAT Small Molecule Drug Substance team who are responsible for supporting the ongoing production of our commercial Life Cycle Management (LCM) API portfolio. They will represent MSAT as part of site-based multi-functional teams, and within global project teams throughout the business, collaborating closely with partners to guarantee smooth and efficient API production whilst ensuring that safety, environmentally sound practices, and quality are embedded in everything we do. The primary focus of this role will be ensuring API manufacturing readiness, identifying and implementing process optimizations, leading non-conformance investigations / Corrective Actions Preventative Actions (CAPA) implementation, supporting process validation and qualification activities, and coordinating technology transfers. The (Senior) Process engineer will also play a leading role in increasing agility and capacity at the Geel site through the application of scientific- and data-driven API manufacturing process improvements and will be recognized as the MSAT site expert for their API syntheses.

Key Responsibilities:

Partnering with the Operations, Quality, and Planning departments for daily operational support of API drug substance synthesis (e.g. campaign preparation, resolution of non-conformances, CAPA implementation, process optimizations, production follow up, etc.)

Leading complex process investigations or product related technical issues

Identifying and implementing Cost Improvement Projects (CIP) (e.g., yield improvements, cycle time reduction, de-bottlenecking, etc.) and process optimizations.

Applying approaches such as process modelling / digital twins, advanced data-driven methodologies (e.g., multivariate analysis, data analytics, AI/ML technology etc.), and process analytical technologies (e.g. infrared spectroscopy, focused beam reflectance measurement) to facilitate improved process understanding, optimizations, and non-conformance investigations.

Building process technology expertise and supporting the evaluation and introduction of new process technologies.

Collaborating closely with the global technology, data, and development functions to design specific technology solutions for optimized syntheses.

Leading/supporting slow moving and obsolete inventory (SLOB) avoidance activities.

Leading internal technology transfers and supporting external technology transfers.

Monitoring process and product performance (Continuous Process Verification, Product Quality Reviews).

Contribution, review, and approval of technical documentation

Technical support in partnership with Quality in regulatory audits and inspections

Qualifications:

• Master’s Degree or PhD preferably in Chemical engineering or Process technology (bioengineering, industrial engineering or chemistry), or proven record in an industrial, operational environment.
• Previous experience or strong interest in chemical synthesis / API synthesis and/or process technology. Experience in an API manufacturing or development environment is an asset.
• Experience or knowledge in one or more of the following areas related to API manufacturing is preferred: organic chemistry, reaction engineering, distillation, liquid-liquid extraction, solid-liquid separation, drying
• Knowledge or strong interest in one or more of the following areas is an asset: process modelling, process analytical technology (PAT), data analytics, multivariate analysis, AI/ML, lean manufacturing (certification is a plus), process excellence (certification is a plus).
• Awareness of API manufacturing site systems and procedures (SAP, complaint handling, change control, qualification, process validation, etc.)
• Good project management, planning, and coordination skills.
• Motivated, able to work independently and take decisions autonomously, with demonstrated problem solving skills and results driven personality.
• Strong interpersonal skills, e.g., influencing and handling conflicting interests.
• Strong analytical skills with a high level of accuracy.
• Able to establish close collaborations with internal and external business partners
• Working knowledge of English (both verbally and written) and Dutch (or willing to develop proficiency in Dutch)