My client is currently looking for a Validation Engineer to join their expanding team. Playing a vital role in the QA department and reporting directly to the Head of Quality, the Validation Engineer will assume responsibility for reviewing and issuing validation protocols and reports. The role involves coordinating the execution of validation activities, including process, cleaning, equipment, and computer qualifications, in collaboration with relevant departments within the organization.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Contribute to the preparation and review of the Validation Master Plan for Process and Cleaning.
- Manage validation requirements for The client and third-party suppliers and CMOs.
- Oversee the preparation, review, and issuance of Validation Protocols and Reports (covering equipment, cleaning, process, and computer system validation).
- Maintain and take responsibility for the cleaning validation strategy at The client.
- Assume responsibility for the cleaning validation master plan adhering to EU competent authorities' practices and demands.
- Implement Process Validation for new products, ensuring compliance with proposed registered specifications for regulatory submissions.
- Coordinate the execution of validation according to protocols by Production, Quality Control, and R&D teams.
- Establish, implement, and direct validation and revalidation activities.
- Liaise with contract manufacturing customers for approval of protocols and reports when required.
- 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 to support validation efforts.
- Ensure completion of validation protocols.
- Conduct Internal Audits as required.
- Lead cross-functional teams to provide expertise in resolving technical issues.
- Assist in preparing and hosting associated regulatory and customer audits.
COMPETENCIES:
- Good verbal and written communication skills; ability to work independently in an analytical environment.
- Proficient in Word, Excel, and other statistical programs.
- Knowledge of Process and Cleaning Validation.
- Ability to conduct internal audits.
- Ability to perform in external audits.
QUALIFICATIONS:
- Minimum Bachelor of Science or Engineering.
- B.Sc. / M.Sc. in Scientific Discipline.
- HPRA / USFDA Experience.
- Minimum 2 years of relevant experience in a similar position.
- Demonstrated ability to work and communicate effectively cross-functionally at all levels of management.
- Proactive, motivated, analytical, and strategic thinker.