Description
An innovative Biopharmaceutical manufacturer, based in Denmark, is currently looking for an experienced Cleaning Validation Engineer to join their team, in line with a continued period of growth.The responsibilities of the Cleaning Validation Engineer are as follows:
* Work as part of the Validation team, following quality systems and requirements laid out by the sites Validation Master Plan, ensuring education and all operational units compliance.
* Maintain and develop current validation procedures, implementing improvements wherever possible, within a Biopharmaceutical manufacturing facility.
* Constant review and generation of company Validation documentation for all exercises and projects including protocols and SOP's.
* Responsible for Equipment Cleaning Validation activities on site, including calibration to agreed standards. THis includes Autoclaves, freeze-driers and drench ovens.
* Monitoring / participation in the implementation of the FAT/SAT and qualification/validation measures, to work together with suppliers and operation personnel.
To fulfil these requirements for the Cleaning Validation Engineer, you must have the following skills/experience:
* Previous experience working as part of a Validation Department within the Biopharmaceutical industry with knowledge of FDA and cGMP requirements.
* Previous Validation documentation responsibilities, including reviewing and generating Protocols/reports. (IQ/OQ/PQ)
* Validation Project management experience would be beneficial including Cleaning validation and equipment validation. (CIP)
* Educated to degree level/equivalent experience.
* Excellent communication and presentation skills.
The successful Cleaning Validation Engineer will have the chance to work in a very reputable company within the Biopharmaceutical industry, during a very exciting period and receive competitive rates of pay.