Job Title: MSAT Process Engineer I – Manufacturing Operations and Compliance Support

About the Job: In your role, you will be responsible for root-cause investigations and continuous improvement initiatives (i.e. CAPA’s) for the companies manufacturing site producing T-cell therapy products.

In your new role, you will be:

• Collaborating with technical and operational stakeholders, writing and/or revising SOPs, batch records, and other operations-related documents;
• Investigating and coordinating the resolution of deviations through comprehensive use of Root Cause Analysis tools;
• Devising and implementing CAPAs to address root cause and ensure effectiveness;
• Performing other tasks and duties as assigned by Management.

Requirements

• You have prior work experience in cell culture, cell therapy and/or aseptic processing.
• You have proven technical knowledge & experience with cGMP compliance and you have experience in leading investigations, writing deviation reports, change controls, and corrective actions.
• You possess excellent communication skills and can work in cross-functional teams to obtain project deliverables.
• You have a working knowledge of scientific and engineering principles.
• You are comfortable in a fast-paced expanding company environment and able to adjust workload based upon changing priorities.
• You can function efficiently and independently in a changing environment.
• You are self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• You can think critically and demonstrate troubleshooting and problem-solving skills.

Knowledge and Experience

• You have BSc in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent; Engineering degree is a strong plus.
• 2-3 years’ relevant process engineer experience within a Pharmaceutical/GMP Manufacturing Site
• Excellent knowledge of manufacturing processes.
• Strong technical writing skills with experience in protocol/report-writing.
• Strong interpersonal skills