Manufacturing Process Specialist - Safety - EHS - GMP

MANUFACTURING PROCESS SPECIALIST/LEIDEN, NETHERLANDS/12 MONTHS CONTRACT/40 TO 46 EUR (PER HOUR)

The Cell Culture department is part of this and is responsible for the quality and safety of processes and the equipment used by the Fermentation, Pre-culture and Bioreactor Assembly departments. In addition, the department is responsible for investigating and immediately resolving (technical) deviations in the production process even outside office hours. The department leads and participates in various projects to optimize the production processes and equipment or to implement new production processes and equipment.

ACTIVITIES AND RESPONSIBILITIES:

As Senior Manufacturing Process Specialist within Cell Culture you are responsible for a product and/or an asset (equipment). This means keeping in good shape, monitoring and improving processes/equipment within the frameworks of EHS, GMP and the MPS.

The Senior Manufacturing Process Specialist:

- Is a knowledge carrier of the fermentation processes.
- Is knowledge carrier of equipment used in cell culture (Fermentation and Preculture).
- Initiates and leads innovations in relation to process and/or equipment. This also includes managing Change Control processes, managing BIs and defining the User Requirements in consultation with other parties. Innovations can be in the areas of capacity, safety (EHS) and quality (GMP).
- Initiates and directs projects related to expansion of production capacity, replacement of equipment, and implementation of new technologies.
- Initiates and leads improvements. Works on ARBO/EHS & S quality improvement.
- Represents Operations Cell Culture in NPI projects and global, multidisciplinary projects in the field of cell culture.
- Is a member of the global Tech Teams of a product.

JOB REQUIREMENTS:

- A completed technical HBO or WO course, for example (bio) pharmaceutical sciences, biotechnology, biochemistry, chemical technology, life sciences.
- HBO level: with work experience
- WO level: with work experience
- Experience with biotechnology and production processes
- Experience as a system/process expert
- Able to function properly both independently and in a team. Can lead teams.
- Communicative skills, decision-making and self-assured.
- A good balance between conceptual thinking and practical technical insight.
- Can work in a strong quality-oriented environment (GMP).
- PE or FPX certification is a plus.

THE COMPANY

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

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