Beschreibung
Job description:Implementation of the maintenance program including calibration and qualification activities:
- Responsible for the planning, implementation and scheduling and implementation of maintenance measures
- Responsible for the planning, implementation and scheduling and implementation of calibration and validation activities
- Coordination of the processes between the process unit (PU), suppliers and contract manufacturers
- Creation of revision and maintenance plans
- Creation of the maintenance and investment budget
- Support TPM development and adapt it to CGT needs.
Is jointly responsible for the implementation and compliance with the legal and internal regulations (SOP’s), guidelines and standards in his unit, especially with regard to quality, HSE.
Detection of systematic quality defects and timely initiation of corrective measures
Creation of standard operating instructions (SOP’s) in the area of responsibility
Create and investigate technical Deviations for the facilities, utilities, equipment and analytical instruments, establishment of root-cause analysis.
Create and perform technical Changes for the facilities, utilities, equipment and analytical instruments. Update and maintain the GMP and technical documentation.
Realizes technical and project processing on behalf of the Site Engineering Lead
Creation of Asset Change Control (ACC) and follow ACC process to implement the project,
Execution of technical projects and cooperation with engineering pharma, owner function
Responsible for the planning, implementation and scheduling and implementation of technical project using ACC (Asset Change Control).
Prepares Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents and perform technical Changes at the facilities, utilities, equipment and analytical instruments.
Ideal Background:
Level of education:
- Hiher education (Bachelor or Master degree) in Engineering
Languages:
- English fluent written and spoken, German is a plus
Experience:
- Leadership experience
MUST HAVES:
- Experience preventive maintenance and corrective within SAP-PM
- Experience in a (pharmaceutical) production environment
Specific Professional Competencies preferred:
- MS-Office, SAP, COMOS, ACC Agile, AQWA