Description
Our client is a pharmaceutical company and is looking for a single-use systems specialist to manage projects related to single-use systems. The process engineer will work at our client in Belgium for at least 6 months.
The single-use systems specialist will:
- Second the Manager in charge of life cycle management of single-use systems to be implemented in manufacturing projects
- Overall planning, action log and daily coordination meeting (with users, development and procurement representatives)
- Do mapping of manufacturing process
- Design of SUS systems
- Translate in specifications
- Coordinate with suppliers or internal teams to get final prototypes
- Create cGMP articles to be used in the manufacturing process,
- Perform commissioning and qualification and support implementation in manufacturing (support to training activities, SOP redaction, etc)
- Issue change management package on these systems when needed (RPC) .
- Coordinate equipment specifications definition, sourcing and qualifications.
The single use systems specialist is/has:
- A Degree in Engineering Chemistry, Physics, Pharma or in Biology
- Basic GMP knowledge, including validation processes
- Technical mindset
- Experience in RPC or CAPA management
- Risk-analysis tools (FMEA)
- Knowledge of project management methods
- General administration, hands-on communication, data analyses & processing
- Knowledge of single-use systems is a plus
- Experience in the Pharmaceutical industry is a must
- Experience in project administration is a must
- Fluent in French and in English