Job Description:
A Lead Validation Engineer is required to lead the overall validation and qualification of equipment and processes. This involves developing the overall validation and qualification plan/strategy in compliance with onsite governing procedures and aligned with the engineering technology department, delivering the overall project.
Key Responsibilities:
* Develop quality validation process flow (e.g., V up to and including Regulatory submission).
* Promote and support an effort to have a common approach to documentation and strategies.
* Lead, support, guide, and coordinate validation activities with the team members to ensure adequate resource assignment, task prioritization, and progress monitoring according to schedule.
* Collaborate with the QA Team to ensure there is agreement to the overall strategy, resolve any issues that arise, and work through the tasks to complete the overall project.
Requirements:
The ideal candidate must have Process/Equipment Validation experience with CSV knowledge. A background in automation process validation, with an understanding (not expertise) of CSV, is also necessary. Understanding of the CSV/software in a machine will be needed. The candidate should be familiar with GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). Additionally, they should have knowledge of FDA 21 CFR Part 11 and ISO standards such as ISO 9001, ISO 13485 (for medical devices), and ISO/IEC 27001 (for information security).