Job Description
The Role: Our client is a leading pharmaceutical company who is dedicated to delivering high quality products and services. They maintain a high standard across all operations by focusing on compliance, efficiency and innovation. They are currently recruiting for a Validation Engineer to join the Quality Assurance department. This person will be responsible for reviewing and issuing validation protocols and reports, as well as coordinating the execution of validation activities (process/cleaning, equipment, and computer qualifications) across relevant departments. Responsibilities: * Contribute to the preparation and review of the Validation Master Plan for Process and Cleaning. * Manage validation requirements for the client and also third-party suppliers and CMOs. * Oversee preparation, review, and issuance of Validation Protocols and Reports, covering equipment, cleaning, process, and computer systems. * Maintain and oversee the cleaning validation strategy, ensuring compliance with EU regulatory standards. * Implement Process Validation for new products to meet regulatory specifications. * Coordinate validation execution with Production, Quality Control, and R&D teams. * Establish, implement, and direct validation and revalidation activities. * Collaborate with contract manufacturing customers to obtain protocol and report approvals as needed. * Review and manage Change Control Forms and Non-Conformances related to validation. * Update quality documentation relevant to validation activities. * Identify and address training needs related to validation. * Ensure completion of validation protocols and maintain validation documentation. * Conduct Internal Audits as required. * Lead cross-functional teams to resolve technical issues. * Assist in preparing for and hosting regulatory and customer audits. Qualifications/Requirements: * Minimum Bachelor of Science/Engineering. * HPRA / FDA experience is desired. * At least 2 years experience in a similar position. * Proven capability to effectively collaborate across functions and communicate with all levels of management. * Proactive, motivated, analytical and strategic individual. * Excellent verbal and written communication skills, adept at working independently in an analytical environment. * Proficient computer skills including Word, Excel, and other statistical programs. * Familiarity with Process and Cleaning Validation principles. * Capable of conducting internal audits. * Able to participate effectively in external audits. By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on (phone number removed)