Description
Validation Engineer required by a world leading pharmaceutical company in the South East of England.As part of ongoing expansion and new Product introduction programme, a Validation Engineer is required on an initial 3 month contract basis with scope for further work thereafter.
This role will involve the production of IQ/ OQ documentation and protocols for the validation of sterile filling equipment and utilities/ facilities.
Role
• 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. (IQ/OQ)
• Responsible for Equipment, Process and Facility Validation activities on site including calibration to agreed standards. Including: Autoclaves, freeze-driers, drench ovens and sterile filling equipment. (Isolators etc.)
• Monitoring / participation in the implementation of the FAT/SAT and qualification/validation measures, to work together with suppliers and operation personnel.
Education and Experience:
• Previous experience working within as part of a Validation department within the pharmaceutical/Biopharmaceutical industry with knowledge of FDA and cGMP requirements. Sterile manufacturer.
• 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.
Please apply now highlighting your validation experience in a
sterile/ aseptic environment.