Role Summary: The Validation Engineer will play a crucial role in the QA department, reporting directly to the Head of Quality.
This position involves reviewing and issuing validation protocols and reports, coordinating the execution of validation activities (process, cleaning, equipment, and computer qualifications) across relevant departments.
Key Responsibilities: * Contribute to the preparation and review of the Validation Master Plan for Process and Cleaning.
* Manage validation requirements for the company and third-party suppliers/CMOs.
* Oversee the preparation, review, and issuance of Validation Protocols and Reports, including equipment, cleaning, process, and computer system validation.
* Maintain and manage the cleaning validation strategy and master plan, ensuring compliance with EU regulations.
* Implement process validation for new products to meet regulatory submission requirements.
* Coordinate execution of validation protocols with Production, Quality Control, and R&D teams.
* Establish and direct validation and revalidation activities.
* Liaise with contract manufacturing customers for protocol and report approvals as needed.
* Review and manage Change Control Forms and Non-Conformances related to validation.
* Update quality documentation related to validation activities.
* Identify and address training requirements for validation support.
* Ensure completion of validation protocols.
* Conduct internal audits and assist in regulatory and customer audits.
* Lead cross-functional teams in resolving technical issues.
* Execute risk assessments and investigation reports related to validation.
Competencies: * Strong verbal and written communication skills.
* Ability to work independently in an analytical environment.
* Proficient in Word, Excel, and statistical software.
* Knowledge of process and cleaning validation.
* Experience in conducting internal and external audits.
Qualifications: * B.Sc.
or higher in Science or Engineering.
* Minimum 2 years of relevant experience.
* HPRA/USFDA experience preferred.
* Proven ability to work and communicate effectively across all levels.
Health & Safety: * Follow health and safety protocols, including PPE use in laboratory and production areas.
* Report any safety concerns or defects promptly.
* Maintain a safe, clean, and tidy work environment.
* Required training: Manual Handling and PC operation.
Work Environment: * Office-based role.
For more information contact Niall on (phone number removed)