Description
We are seeking a highly motivated and experienced Cell Processing Engineer to lead the design, maintenance, and continuous improvement for our client in Ghent. The role involves overseeing cell processing manufacturing activities, supporting manufacturing processes (such as media preparation and sterilization), and managing logistical operations (including logistics center and work-in-progress).
Collaboration with cross-functional teamsincluding operations, MSAT, quality assurance, engineering, and external vendorsis essential to ensure smooth operations and compliance with quality standards.
Key Responsibilities:
* Develop and maintain a deep understanding of manufacturing processes, including cell processing, immunology, regulatory frameworks, and operational procedures.
* Draft, review, and approve operational instructions, procedures, and logbooks to align with biosafety and quality standards.
* Act as the Subject Matter Expert (SME) in operations, providing input, reviews, and approvals for documentation affecting the production system.
* Lead and support risk management initiatives impacting operations.
* Conduct root cause investigations for biosafety and quality issues; create and implement robust corrective and preventive action (CAPA) plans.
* Represent the production system during health care inspections.
Your profile
* At least 3 years of experience in cell processing, immunology, and manufacturing operations.
* Master's degree in a pharmacological field
* Strong understanding of regulatory frameworks and quality standards in cell therapy or biotech environments.
* Excellent problem-solving, risk management, and investigation skills.
* Ability to work effectively with cross-functional teams and external partners.
* Strong communication skills and the ability to represent your area during inspections.
What's in it for you?
Full-time contract. (Freelance also possible)
You will be part of a growing Belgian SME where initiative and personal development are encouraged. We will provide you with an enjoyable work environment with fun colleagues. We will work out a career plan with you, with attention and a budget for extra education/certification. You can count on an attractive salary, supplemented with extra-legal benefits, including a company car.