Senior Validation Engineer, Scientist (Sterilization), Sterile Drug Product Manufacturing, Science & Technology Working with Us
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Position Summary BMS Cruiserath Biologics is seeking to recruit a permanent Senior Validation Engineer/Scientist (Sterilization), Sterile Drug Product Manufacturing, Science & Technology. Reporting to the Associate Director process engineering, Sterile Drug Product Manufacturing, Science & Technology, this role will be the Validation Lead for all validation aspects of all process equipment being installed in a new Sterile Drug Product Manufacturing Facility being built on the Cruiserath campus. The successful candidate will be part of a multi-functional team charged with the delivery of the significant capital investment and will be accountable for all sterilization and cleaning validation aspects of the process equipment. Upon completion of the project, you will continue to support the sustaining operation on site as well as acting as a global Subject Matter Expert (SME) within the organization.
Key Responsibilities Develop a strategy to ensure that the validation approach for the new SDP facility satisfies the requirements of all regulatory bodies; regulations, standards, guidance and GMP, including effective and appropriate use of process development. Development and execution of allocated validations according to the SDP Validation Master Plan. Produce and maintain appropriate and comprehensive validation policies and procedures. Act as lead for all technical and equipment validation activities from design to successful PPQ of products within the SDP facility, and after which will support routine production of the facility. Manage the activities of a defined team of Validation Engineers. Management responsibilities to include day to day work allocation and prioritisation of work, performance and output quality review, coaching, training, internal communications, and general personnel assistance during their duties. Ensure that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements. Provide input, monitor, and report compliance on the content of the Validation Master Plan in conjunction with the appropriate Primary teams, and corresponding Management Reviews. Ensure the review and approval of validation lifecycle documentation and ensure they are written in accordance with the company standards and procedures. Develop and maintain processes and procedures to ensure product tech transfers are achieved efficiently. Draft and approve test protocol and reports as required along with supporting the execution of IQ/OQ and PQ activities for SDP during start up as required. Publish site specific progress reports as required. Quality of completed validations [Effectiveness, schedule adherence, minimum deviations]. Validation SME in regulatory audits and inspections. Support site change control procedures. Any other reasonable duties which may be required by management. Qualifications & Experience Deep technical knowledge of Sterile Drug Product manufacturing equipment validation and sterilisation, specifically in the areas of sterile filling and associated equipment. Knowledgeable on current industry practices and regulatory requirements within the Sterile Drug Product manufacturing area. Familiar with start-up of new Sterile Drug Product manufacturing facility from initial design through to the final qualification of the equipment. First-hand experience of qualification and validation of Sterile Drug Product manufacturing equipment and/or processes, specifically in the area of Sterile Filling and Isolator equipment. The successful candidate must possess a Bachelor/master's in engineering, or Science related discipline. A minimum of 5 years' experience within a Sterile Drug Product Manufacturing is essential. Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture. Experience with Qualification and Validation of new equipment is essential, as well as experience interacting with regulatory agencies. Experience with Technical Transfer of new processes is desirable. The candidate will have demonstrated proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills. Problem solving and project management ability, as well as lean manufacturing experience is essential. Why you should apply You will help patients in their fight against serious diseases. You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym. #LI-Hybrid
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