Project Database Engineer - Puurs, Belgium
Job Title: Project Database Engineer
Location: Puurs, Belgium
Duration: 12-Month Contract
Rate: To be Discussed
A leading global Biopharmaceutical company specialising in biological injectables in Puurs (Antwerp) is looking for a Dutch-speaking Project Database Engineer, to join their experienced team on a 12-month contract basis. The candidate will be responsible for aseptic validation design strategies, validation activities, and the implementation of a database to log environmental monitoring samples within the company's aseptic manufacturing facility.
• Preparation of the URS for test equipment
• Preparation of the validation plan and final validation reports
• Coordination and follow up of the practical execution of the validation tests
• Identify and close system performance or compliance gaps according to cGMP/Pfizer regulation
• To improve the efficiency of the systems and make sure that the correct SOPs/WI are in place
• Aseptic Validation of Processes/Clean Rooms & Equipment
• Assures that test methods used comply with current legal and company standards.
• Prepares a maintenance/calibration program that ensures that the used equipment is well maintained, validated and calibrated at regular intervals according GMP requirements and company guidelines.
• Assures proper training and development of personnel concerning the assigned projects to obtain a proper transfer to the routine testing process.
• Improve productivity and avoid unnecessary costs in relation to the assigned projects and plans for timely implementation.
• Serves as a coordinator between the Aseptic design/ Micro lab and other departments such as Product Support, engineering, production, maintenance, the chemical lab and environmental control operations.
• Participate in corporate and site teams and audits related to his/her expert domains.
• University degree in the chemical, pharmaceutical and/or biological engineering or scientific field.
• Broad experience in pharmaceuticals - with a minimum of 3 years in the industry
• Interest in environmental monitoring of facilities
• Interest in PC-systems required
• FLUENT written and spoken Dutch and English
If you are interested in this opportunity, please send your CV to firstname.lastname@example.org
Alternatively, call 01625537555 (extension - 1024)
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