Process Engineer MSAT

The Process Engineer supports Manufacturing Science & Technology (MSAT) activities associated with technologies, processes, and controls. This role encompasses technology transfer management, manufacturing support and process improvement initiatives.

The Process Engineer operates at the interface between Process Development and Operations, ensuring efficient information exchange and alignment of objectives in accordance with the company’s overarching strategy.

You will work in our Belgium facilities (Villers-Le-Bouillet) interacting with multiple teams including Process Development, Analytical Development, Manufacturing, QA/QC, Regulatory, Business, etc.

PRIMARY RESPONSIBILITIES (include but are not limited to)

Process Expertise

·       In close collaboration with Development and Operations teams, ensure technology watch, identify improvement opportunities and implement when appropriate.

·       Evaluate capacity increase requirements to support business growth.

·       Document the state of the science and technology and share knowledge with relevant stakeholders.

·       Meet business needs by ensuring compliance and operational readiness.

·       Be able to interpret regulatory requirements for the relevant cells-based starting material field.

·       Strengthen internal capabilities, identify capabilities gaps and develop appropriate solutions to meet business need.

·       Maintain compliance with regulatory requirements and guideline for the concerned field.

·       Draft and review investigations including impact assessments, risk assessments (FMEA), corrections, CAPAs, and Change Controls.

·       Provide technical support to Process Development, including troubleshooting and introduction of new technologies.

·       Act as the interface between Production, and Development, ensuring appropriate backup when necessary.

·       Support product and process data analysis.

·       Assess major deviations for impact on product quality.

Technology Transfer

·       Supervise technology transfers from clients or internal development to processing units.

·       Support the IntegriCell platform in the evaluation of customer requirement for process design or technological aspects, as well as business aspects.

·       Ensure application of Quality by Design (QbD) on processes to be transferred or developed.

·       Perform technical and feasibility assessments of new project.

·       Generate technology transfer risk assessment, protocol and report in collaboration with peers.

·       Establish and maintain departmental procedures.

·       Travel up to 10%: support implementation of technologies across Cryoport Systems sites abroad and attend to conferences.

COMPETENCIES & PERSONAL ATTRIBUTES

·       Proven experience in biological manufacturing and aseptic processes.

·       General knowledge of Quality by Design (QbD) principles and risk management.

·       Ability to interpret regulatory requirements for cell therapy starting material.

·       Strong cross-functional collaboration and communication skills.

·       Strong proficiency in Microsoft Office Suite.

·       Fluency in English and French (written and spoken).

·       Structured and analytical problem-solving approach.

·       Basic knowledge in statistics.

·       Strong self-motivation and the ability to work independently is a must have.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

·       Bachelor or Master’s degree in a scientific domain (Biology, Biomedical Science, Biochemistry, etc.)

·       A proven experience of min. 3 years in a similar role