Process Engineer

Opdrachtgever

Our client is a leading consulting and engineering firm in pharma, food and chemistry.

You have BSc in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent; Engineering degree is a strong plus.
You have prior work experience in cell culture, cell therapy and/or aseptic processing experience.
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.

Responsible for impact assessments supporting product release, root-cause investigations, continuous improvement and projects.
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.
Other tasks and duties as assigned by Management.