Sterilisation Validation Engineer I Requirements: Support routine Sterility Assurance activities e.g GMP, Standards Compliance, Cleanroom Risk Assessment, Limits review, Dose Audit activity, Cycle Requalification, Supplier Change control etcSupport sterility assurance activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sitesParticipate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementationSupport cross functional teams in design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standardsCollaborates with engineering and manufacturing functions to ensure quality standards are in placeDevises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.Performs calculations, data integrity checks, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirementsAdhere to all relevant site wide procedures and practices for Safety & GMPSPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Entry level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities. Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems. Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information. Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a University Degree, 1-2 years of experience required. Support new product launch as part of the Product Development Process ensuring that CQXM requirements are included in the process. .
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