Job Description:
The Validation Engineer is a key role in the QA department, reporting directly to the Head of Quality. The successful candidate will be responsible for reviewing and issuing validation protocols and reports, as well as coordinating the execution of validation activities with relevant departments.
Main Responsibilities:
* Contribute to the preparation and review of the Validation Master Plan - Process and Cleaning.
* Manage validation requirements and third-party suppliers and CMOs.
* Prepare, review, and issue Validation Protocols and Reports (including equipment, cleaning, process, and computer system validation).
* Maintain and take responsibility for the cleaning validation strategy.
* Assume responsibility for the cleaning validation master plan, adhering to accepted practices and demands of competent authorities in the EU.
* Implement Process Validation of new products for regulatory submissions, ensuring compliance with proposed registered specifications.
* Coordinate the execution of validation in accordance with protocols by Production, Quality Control, and R&D teams.
* Establish, implement, and direct validation and revalidation activities.
* Liaise with contract manufacture customers to seek approval for protocols and reports where appropriate.
* Review and manage Change Control Forms for Validation implications.
* Review and manage Non-Conformances for Validation Implications.
* Update existing quality documentation related to validation activities.
* Identify training requirements in support of validation.
* Ensure completion of validation protocols.
* Carry out Internal Audits as required.
* Responsible for the execution of Risk Assessments or Investigation reports relative to the role.
* Maintain validation documentation system.
* Lead cross-functional teams providing knowledge in resolution of any technical issues.
* Assist in the preparation and hosting of associated regulatory and customer audits.
Requirements:
* Bachelor of Science or Engineering degree.
* HPRA/USFDA experience.
* Minimum 2 years' experience in a similar position.
* Demonstrated ability to work and communicate effectively cross-functionally with all levels of management.
* Proactive, motivated, analytical, and strategic thinker.
* Good verbal and written communication skills, and ability to work independently in an analytical environment.
* Good computer skills with Word, Excel, and other statistical programs.
* Knowledge of Process and Cleaning Validation.
* Ability to conduct internal audits.
* Ability to perform in external audits.