Description
An innovative Pharmaceutical manufacturer based in the South-East is currently looking for an experienced Validation Engineer to join the team in line with a continued period of growth.The responsibilities of the 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 unit 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, Process and Facility Validation activities on site including calibration to agreed standards. Including: 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 Validation Engineer you must have the following skills/experience:
* Previous experience working within 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 equipment calibration and commissioning, Cleaning validation and equipment validation.
* Educated to degree level/equivalent experience.
* Excellent communication and presentation skills.
The successful 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.