Pharmaceutical Process Validation

Job Title: Engineering Validation Specialist Role Overview: We are seeking an experienced Engineering Validation Specialist to join our team. As a key member of our validation team, you will be responsible for supporting the development and execution of qualification and validation activities across various areas. Your primary focus will be on designing, authoring, reviewing, and approving qualification and validation documentation, as well as developing change controls and resolving technical issues during study execution. You will also engage with production, maintenance, and quality representatives to ensure smooth execution of cycle development and performance qualification activities. You will be expected to provide technical input into quality notifications by authoring, reviewing, and approving investigations. Additionally, you will perform root cause analysis of system failures and substandard performance using standard tools and methods to resolve machine and system issues. Key Responsibilities: Design and develop qualification and validation documentation Execute qualification and validation activities Develop and implement change controls Resolving technical issues during study execution Engage with cross-functional teams to ensure smooth execution of validation projects Requirements: To excel in this role, you will need: A relevant technical qualification in applied pharmaceutical or biological sciences or a technical/engineering qualification Experience operating as an individual contributor adding value to a business in a GMP manufacturing setting Knowledge of CTU equipment qualification, thermal mapping equipment, and sterile fill-finish processes and equipment Demonstratable experience of leading technical-related projects Excellent communication, presentation, and interpersonal skills Benefits: This is an excellent opportunity to work in a dynamic environment where you can utilize your skills and expertise to contribute to the success of our organization. You will have the opportunity to work collaboratively with cross-functional teams and take ownership of validation projects from conception to completion.

Creado: Jue, 01 de Ene de 1970