We are currently looking for a Senior Validation Technician to join a leading Pharmaceutical company based in the Hertfordshire area. As the Senior Validation Technician you will be in collaboration with Validation Specialists and Management to develop and implement validation strategies to deliver compliant and efficient validation lifecycle documentation.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Validation Technician will be varied however the key duties and responsibilities are as follows:
1. You will be responsible to highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.
2. The Senior Validation Technician will ensure test execution complies with HSE, cGMP, Validation Plans and Polices as well as ensure valid results and data can be used as evidence in validation protocols and reports.
3. It will be crucial to ensure adequate regulatory knowledge and understanding of cGMP EU & FDA regulations associated with the testing process equipment including Autoclaves, Depyronisation Tunnels, Aseptic Filling, Pasteurisation Vessels, Cold Room Storage.
4. Another duty will be to ensure all validation equipment is correctly calibrated, routinely inspected and tested to ensure correct operation, performance and valid test results. You will also ensure all validation test equipment is correctly managed in respect to secure storage, adequate controls and correct use during routine / requalification testing.
5. You will be accountable for the ongoing compliance of all assets at the Hertfordshire facility within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
To be successful in your application to this exciting opportunity as the Senior Validation Technician we are looking to identify the following on your profile and past history:
1. The ideal candidate will hold a degree level qualification in a science or engineering discipline or equivalent.
2. It is essential for the candidate to have industry experience in validation within a parenteral (bio)pharmaceutical or blood products manufacturing environment (API and/or fill/finish).
3. The company are interested in candidates that have an ability to assimilate new information into their routine working practices and adequate training, understanding and practice of testing equipment including Kaye Data loggers, Yokogawa Chart Recorders, Thermocouples.
Key Words: Validation | Technician | Continuous Improvement | Biopharamaceutical | API | Equipment | GxP | Pharmaceutical | Life Sciences | Calibration |