We are currently looking for a Validation Engineer to join a leading Pharmaceutical company based in the Cambridge area. As the Validation Engineer you will be responsible for validating/qualifying the systems and equipment used to develop and/or manufacture sterile products within a pharmaceutical manufacturing company (CPL). The Engineer will also lead key validation activities in a new sterile manufacturing facility whilst having a focus on cleaning, sterilisation, liquid product process validation.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Engineer will be varied however the key duties and responsibilities are as follows:
1. You will prepare validation and performance qualification protocols for new equipment, and revalidation, where appropriate, of new and/or existing manufacturing equipment and support systems.
2. The Validation Engineer will develop, prepare, and install new equipment and revise test validation procedures/protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirements and current industry practices.
3. Another duty will be to coordinate on projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied to procedure during the execution of protocols.
4. It will be essential to coordinate the implementation or scheduling of validation testing with affected departments and personnel. You will create, populate, and maintain databases for tracking validation activities, test results, and validated systems.
To be successful in your application to this exciting opportunity as the Validation Engineer we are looking to identify the following on your profile and past history:
1. Relevant Bachelor's degree in Science, Biology, Chemistry or Engineering is preferred.
2. Proven industry experience in validation is preferred or related quality experience in a
cGMP Device or Drug environment. It is also preferred to have experience in a Pharmaceutical or Medical Device manufacturing environment.
3. A working knowledge of EU GMP, ISO and FDA Regulations/Guidance, and Good Documentation Practices is essential.
Key Words: Validation | Engineer | Medical Devices | Pharmaceutical | Equipment | Sterile Products | Cleaning | Sterilisation |