Validation Engineer
This is an exciting opportunity for a skilled professional to join our organization. You will be responsible for creating and executing validation documentation and coordinating validation activities for various processes and facilities within the quality management system.
Key Responsibilities and Deliverables:
* Create and execute validation plans, protocols, reports, and amendments of the Quality Management System, ensuring compliance with regulatory agencies directives/requirements.
* Develop applicable quality documentation in conjunction with validation activities.
* Liaise with cross-functional teams to provide and drive validation inputs and initiatives into operational activities.
* Liaise with external vendors for validation plans and requirements.
* Develop validation projects and master validation plans.
* Support implementation of company policies and Good Manufacturing Practices (GMP).
* Ensure ongoing compliance with GMP in all practices, recording of events, and processes.
* Perform and generate risk assessment documents for regulated processes within the scope of the QMS.
* Participate and drive quality GMP audits.
* Knowledge and use of LEAN 6 sigma tools for problem solution.
Requirements:
* Bachelor's degree in Engineering or Science discipline.
* 1 to 3 years' experience in a Validation or Quality engineering role.
* Ideal knowledge of process validation and capability, method validation, and process characterization.
Skills and Attributes:
1. Knowledge of validation and quality principles and practices, emphasizing EudraLex, ISO13485, ISO14644, GAMP5, and FDA Pharma and medical devices regulations.
2. Ability to work in a cross-functional team environment, with excellent initiative, decision-making, and drive for achieving results.
3. Excellent technical report writing, time management, computer, and presentation skills.
4. Excellent interpersonal and communication skills.