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 CleaningManage the validation requirements of the business and third-party suppliers and CMOsManage 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 strategyAssume responsibility for the cleaning validation master plan, confirming to accepted practices and demands of the competent authorities in the EUImplement Process Validation of new products for regulatory submissions ensuring compliance with proposed registered specificationsCoordinate the execution of Validation in accordance with protocols by Production, QC, and R&D teamsEstablish, implement, and direct validation and revalidation activitiesLiaise with contract manufacture customers in seeking their approval for protocols and reports where appropriateReview and manage Change Control Forms for Validation implicationsReview and manage Non-Conformances for Validation implicationsUpdate existing quality documentation related to validation activitiesIdentify training requirements in support of validationEnsure completion of validation protocolsCarry out Internal Audits as requiredExecute Risk Assessments or Investigation reports relative to the roleMaintain the validation documentation systemLead cross-functional teams providing knowledge in resolution of technical issuesAssist in the preparation and hosting of associated regulatory and customer auditsPossess knowledge of Process and Cleaning ValidationDemonstrate ability to perform in external auditsAdhere 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 workAdhere to safety regulations by ensuring correct usage of PPE in laboratory and production areasReport 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 siteQualifications Minimum Bachelor of Science or EngineeringB.Sc. / M.Sc. in a Scientific DisciplineMinimum 2 years of relative experience in a similar positionHPRA / USFDA ExperienceDemonstrated ability to work and communicate effectively cross-functionally with all levels of managementFor more information, please email ******
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