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Engineering Change Coordinator
Integrated in the Engineering Services department and within the scope of technical activities, the engineering change coordinator handles change requests on critical equipment and processes. Together with technical experts, a Quality and Regulatory representative, the engineering change coordinator is responsible for gathering appropriate information on the change to be implemented in order to assure a correct and structured impact assessment and change plan, documented in the TrackWise System. He/she establishes an effective communication between the involved experts and makes sure that the change proceeds in a timely manner.
- Collects information relative to the to be implemented change near the involved departments
- Writes the documentation relative to the change request in a structured, rigorous and detailed manner
- Performs a complete quality assessment together with the Quality department
- Assures that an adequate regulatory assessment is made
- Defines the change plan and sequences the tasks needed to accomplish the change request
- Works with the functional leads to schedules people and resources for each task
- Encodes all the information related to the change request in the TrackWise system
- Provides status updates to management
- Reviews all completed taks before implementation
- Coodinates the change requests with respect to targets
- Develops and maintains an effective communication with the expert departments (Quality, Regulatory Affairs, Engineering, Maintenance, Metrology, Environmental Monitoring, Production, Validation)
- Assures a supportive role during audits
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Knowledge and understanding of manufacturing process and used technologies
- Knowledge of Quality requirements (USP, FDA, Eudralex)
- Collaboration & teamwork
- Good communication in order to achieve alignment between different implicated departments
- Assure a correct follow up of the change requests
- Motivate people in continuous improvement
Decision-making and Autonomy
- Critical Thinking
- Autonomy in change request management
Regular interaction with Quality Operations, Quality Systems, Regulatory Affairs, Engineering, Maintenance, Metrology, Environmental Monitoring, Production, Validation.
- Demonstrate intrest in used equipments and technologies
- Eager to learn
Domonstrate ability to handle different topics at different departments (Purification, Finishing, Utilities) at the same time.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education / experience
- Master in Engineering or Science or Quality
- 2-3 years of experience in a pharmaceutical environment
Core Competencies / Skills
- Effective communication
- Organised, stuctured, rigorous
- Good writing skills in English, good speaking and writing skills in French
- Focus on the overall picture
- Excellent knowledge of MS Office
- Good French and English knowledge
- Stress resistant
- Knowledge of quality regulations (GMP, GDP, FDA, Eudralex)