Company: Multinational pharmaceutical company
Department: Manufacturing - Site Manufacturing Technology
Our client is establishing a project team dedicated to implementation of MES (Manufacturing Execution System) and EBR (electronic batch record) at the manufacturing site in Hoofddorp. We are seeking a highly motivated Process Engineer to represent the Manufacturing – Site Manufacturing Technology (SMT) in the project team.
The project is coordinated globally and therefore collaboration with US (West-Coast) colleagues is required. Therefore, flexibility in terms of working hours might be required.
- Participate in the design and implementation of electronic batch records within a Manufacturing Execution System (MES)
- Provide front line technical support for manufacturing during MES engineering and validation runs
- In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of project related deviations through comprehensive use of Root Cause Analysis tools and product impact assessments.
- Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents
- Trends key performance metrics
- Conducts technical training and guidance to the Cell Therapy Specialists
Requirements / Qualifications:- BS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 4+ years of relevant industry experience or MS with 2+ years of relevant industry experience
- Cell therapy, cell culture and/or aseptic processing experience
- Broad knowledge of cGMP compliance and experience with leading investigations, deviation reports, change controls, and assignment of corrective actions
- Experience with root cause analysis tools and proficiency in Quality Systems
- Possess strong communication and technical writing skills
- Experience leading cross functional teams to achieve project deliverables
- Working knowledge of scientific and engineering principles
- Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus
- Knowledge of manufacturing execution systems (MES), Werum PAS|X, is desirable