Manufacturing Process Engineer

 Lead the development and implementation of an aseptic process including:
 Project planning and management (timelines, coordination and budget)
 Translation of Aseptic Process Guidelines and Regulations/Standards into compliant operational solutions and procedures
 Lead pFMEA including coordination and implementation of associated measures.
 Preparation of supportive documentation (URS, design specifications, protocols, procedures, reports)
 Manage the sourcing of components, materials and equipment.
 Manage Equipment and Process validation activities and documentation
 Manage sub-contractors
 Purification and formulations processes improvement, optimization and scale-up
 Technology transfer from R&D to production
 Manage and investigate process-related discrepancies and propose related CAPA

Position requirements
 A first and successful experience in aseptic processes set up and implementation is a must
 M.Sc. in biotechnology, or chemical engineering, or engineer with experience in biotechnology/pharma industries
 3-5 years  experience in the pharma or biotechnology industries
 Deep understanding in Quality assurance, ISO and GMP practices and documentation
 Fluent English
 Excellent English writing skills
 Hands on MS Project experience

Personal Skills
 Excellent Project Management Skills: Planning, Prioritization, co-ordination, set and meet timelines)
 Team player
 High motivation, innovation and proactivity
 Multitasking
 Details oriented