Company: Multinational Biotech Company
Location: Amsterdam Area
Start: December 2021
Currently we are looking for a Manufacturing Engineer who is willing to contribute to the exciting journey in the development of innovative immunotherapies.
As Manufacturing Engineer, you’ll be joining a team, in which employees of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity. You’ll be reporting to the (Senior) Manager Manufacturing Technical Services (MTS).
In this role you will be part of the technical team responsible for new technology implementation/facility expansion at our commercial manufacturing site producing autologous T-cell therapy products.
• Give input on facility design and define equipment requirements on behalf of the manufacturing department
• Implement new manufacturing equipment and processes:
o Drafting of user requirements specifications
o Review of IOQ and PQ documentation
o Move of equipment into facility
o Support execution of IOQs and PQs
o Draft operational documentation
o Conducts technical training and guidance to the Cell Therapy Specialists
• Investigates and coordinates the resolution of exceptional conditions/deviations through comprehensive use of Root Cause Analysis tools
• Issues and implements Change Controls
• Coordinates between internal stakeholders: Manufacturing shop floor, Facilities and Engineering, Quality Assurance, Quality Engineering, MSAT and other project team members
• BSc in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent.
Knowledge and Experience
• Minimum 5 years of experience, preferably relating to cell culture, new equipment implementations and/or aseptic processing
• Experience with working in cross-functional project teams
• Experience with equipment validation
• Experience with new process implementation
• Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions
• Proficiency in Quality systems
• Utilizes technical writing strategies to ensure content is clear and concise
• Possesses good communication skills
• Experience leading cross functional teams to obtain project deliverables
• Working knowledge of scientific and engineering principles
• Cleanroom environment
• Comfortable in a fast-paced expanding company environment and able to adjust workload based upon changing priorities.
• Ability to function efficiently and independently in a changing environment
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Collaborate well in cross-functional matrix environment, ability to communicate and work independently with scientific/technical personnel.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
If you are interested in this position and/ or would like to learn more about this position, please apply! If you have additional specific questions about the positions or remarks please do not hesitate to contact me on the below contact details.
Stijn van der Kleij