Validation Engineer
Our client, a well-established global manufacturer of pharmaceuticals, is looking to recruit a Validation Engineer to report directly to the Head of Quality. The Validation Engineer will be responsible for reviewing and issuing validation protocols and reports and coordinating the execution of validation activities (process, cleaning, equipment, and computer qualifications) with the relevant departments.
Responsibilities
* Contribute to the preparation and review of the Validation Master Plan – Process and Cleaning
* Manage the validation requirements of the business and third-party suppliers and CMOs
* Manage the preparation, review, and issuing of 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, confirming to accepted practices and demands of the 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, QC, and R&D teams
* Establish, implement, and direct validation and revalidation activities
* Liaise with contract manufacture customers in seeking their 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
* Execute Risk Assessments or Investigation reports relative to the role
* Maintain the validation documentation system
* Lead cross-functional teams providing knowledge in resolution of technical issues
* Assist in the preparation and hosting of associated regulatory and customer audits
* Possess knowledge of Process and Cleaning Validation
* Demonstrate ability to perform in external audits
* Adhere to Health & Safety requirements (e.g., Manual Handling Training)
* Take reasonable care for their own safety, health, and welfare at work and that of any other person that may be affected by their actions or omissions while at work
* Adhere to safety regulations by ensuring correct usage of PPE in laboratory and production areas
* Report to the supervisor or health and safety representative any defects in plant, equipment, place of work, system, or work which might endanger safety, health, or welfare of themselves or any employee on site
Qualifications
* Minimum Bachelor of Science or Engineering
* B.Sc. / M.Sc. in a Scientific Discipline
* Minimum 2 years of relative experience in a similar position
* HPRA / USFDA Experience
* Demonstrated ability to work and communicate effectively cross-functionally with all levels of management
For more information, please email eanna.grealy@cpl.ie
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