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We are currently looking for a Project engineer microbiolab.
The consultant is responsible for the aseptic validation design strategies, validation activities and implementation of a database which is used to log routine environmental monitoring samples in an Aseptic Manufacturing facility.
The tasks consist of :
· Validation activities of the database (part of a global team, requires frequent communication in English)
· Implement database in the organization (local implementation at the Puurs site, this includes coordination of the installation, writing or adjusting work instructions, train users etc.)
· Improve current processes (use the new features of the database system to improve current processes)
The main project is the validation and implementation of the database. Other improvement projects can also be part of the tasks. A broad interest in environmental monitoring of facilitiesis required.
1. Responsible for the validation activities:
- Preparation of the URS for test equipment
- Preparation of the validation plan and protocol
- Coordination and follow up of the practical execution of the validation tests
- Preparation of the final validation report
2. Must become an expert in the following domains:
- Aseptic Validation of Processes/Clean Rooms & Equipment
- Knowledge and correct interpretation of all involved cGMP regulation
- Support in problem solving
3. The contractor can be owner of a Quality System
- to identify and close system performance or compliance gaps according to cGMP/ regulation
- to improve the efficiency of the systems
- to make sure that the correct SOPs/WI are in place
- to share the system knowledge with team members/involved colleagues from production, engineering, QA.
4. The consultant directs analysts if applicable, who are appointed to specific tasks for the assigned projects. She/he is responsible for the reliability of the obtained results and final validation reports.
5. He/she assures that test methods used comply with current legal and Pfizer standards.
6. Prepares a maintenance/calibration program that assures that the used equipment is well maintained, validated and calibrated at regular intervals according GMP requirements and guidelines.
7. Assures proper training and development of personnel concerning the assigned projects to obtain a proper transfer to the routine testing process.
8. Improve productivity and avoid unnecessary costs in relation to the assigned projects and plans for timely implementation.
9. Serves as a coordinator between the Aseptic design/ Micro lab and other departments as Product Support, engineering, production, maintenance, the chemical lab and environmental control operations.
10. The contractor proposes for his expert domain personnel- and equipment budgets and prepares comparative studies on equipment to be purchased.
11. The contractor will participate in corporate and site teams and audits related to his/her expert domains.
12. He/she is responsible for the safety in his/her expert domain.
Degree: This function requires a university degree in the chemical, pharmaceutical and/or biological engineering or scientific field.
Experience required: He/She should have a broad experience in general with a minimum of 3 years in the industry (good junior or medior/senior).
Interest in PC-systems required
Knowledge and understanding of cGMP is a must.
Special training and skills:
· Good analytical and problem solving skills.
· Good influencing skills
· Work efficiently with people of different backgrounds.
· The candidate must write and speak Dutch and English fluently.
· Good communication and leadership skills to lead interdepartmental project teams
· Good technical writing skills.
Why working as a consultant for XPE Pharma & Science?
• XPE is a part of Adecco, one of the Top 2 companies within the 'Great Place to Work' ranking
• Dynamic colleagues with passion and drive
• The opportunity to develop yourself, your competences and skills within our organization
• An interesting salary with extra-legal benefits. We offer meal vouchers, group- and hospitality insurance.
Not ready to apply, or have some questions first? Call me on Asmae +32492231817 to discuss in confidence.
Asmae El Addad
0492 23 18 17