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Single-use Systems Specialist
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Client, Engineering, Engineer
Projektbeschreibung
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
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
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik