Senior Validation Engineer
We are seeking a Senior Validation Engineer to oversee and manage the validation and Advanced Product Quality Planning (APQP) lifecycle.
In this pivotal role, you will lead the design transfer process and ensure the technical aspects of the validation lifecycle are executed effectively.
You will also drive continuous improvement initiatives to enhance processes and maintain the highest quality standards.
Responsibilities:
* Lead the validation team for all technical and equipment validation projects in line with pre-determined protocols and production requirements.
* Ensure that the design, installation, and operation of Plant and Equipment have been validated in compliance with current regulatory requirements.
* Develop a strategy to ensure that the validation approach satisfies the requirements of all regulatory bodies; regulations, standards, guidance, and GMP, including effective and appropriate use of process development and DOE activities.
* Produce and maintain appropriate and comprehensive validation policy and procedures.
* Ensure execution of allocated validations according to the plant Validation Master Plan.
* Provide input, monitor, and report compliance on the content of the Validation Master Plan in conjunction with the appropriate Primary teams, and corresponding Management Reviews.
* Write and implement validation system documentation as required.
* Ensure the review and approval of validation lifecycle documentation and ensure it is written in accordance with the company standards and procedures.
* Develop and maintain processes and procedures to ensure product and process transfers are achieved efficiently.
* Liaise with Operations, Planning, and Engineering groups to ensure successful validation of all manufacturing processes.
* Manage the activities of a defined team of Validation Engineers.
Experience and Education Requirements:
* BSc/BEng or a similar relevant technical degree.
* A minimum of 5 years' high-volume engineering experience in medical device manufacturing.
* A minimum of 3 years' validation experience.
* Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt), Sampling Plans/Sizes.
* Process development experience (DOEs etc).
* Risk Analysis/Risk Management, FMEAs, etc.
Skills:
* Validation engineer/validation scientist/manufacturing