Beschreibung
Objective:Complete processing of the planning, realisation and transfer of a project to the Production expansion at the Bad Aibling site.
Planning of all necessary equipment for the manufacture and packing of pharmaceutical.
(eg strip packaging machines, tablet presses, Cartoner handlers equipment).
- TGA and government planning.
- Interface clearing to the trade union building and to the affected departments.
- Preparation of plans and implementation according to the ISPE standard (CD, BD, DD and Commissioning/Hand over).
- Preparation of gate reviews for corporate engineering.
- Processing of all project sections, taking into account SOPs, state of the art and Current standards.
- Involvement in team meetings on the projects.
- Creation of project plans and layouts.
- Creation of timelines and budget planning within the area of responsibility and Control of compliance.
- Reporting on Head Engineering on site.
- Creation and processing of CAPAs and change controls within the framework of the project.
- Co - operation and support department - related and central audits project.
- Creation of the URS for the investment project
- Match with the users
- Coordination with suppliers
- Coordinate with QS
Maintenance (plans and checklists)
Key indicators (indicators, activities on which the success of the job can be measured):
- Profound knowledge of Solids production (bulk & packaging).
- Experience in HVAC & Cleanroom planning.
- Proven experience in the field of pharmacy (at least 5 years).
- Experience TGA planning.
- Creation and updating of time and cost planning.
- Secure handling of CAD drawings and layouts.