PpThe Qualification and Cleaning/Sterilization Validation Subject Matter Expert (SME) is a role within the Technology Lifecycle Excellence (TLE) team. This function leads/supervises Qualification and Cleaning/Sterilization Validation projects. It is the responsibility of this function to implement new systems and processes to a state of permanent inspection readiness. The person ensures the success of the unit by maintaining a strategic focus and a high customer service level, fostering a high-performance organization, and effectively collaborating across the organization. The position ensures a culture of self-direction, empowerment, and accountability, while providing the support necessary to team members working in a widely cross-functional organization. /p h3Responsibilities /h3 ul liLead coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations. /li liResponsible for the development / review / improvement of Qualification and CSV, Cleaning/Sterilization Validation Documentation: such as SOPs, qualification/validation documents, reports. /li liResponsible for compliance deliverables and technical deliverables related to qualification and validation. /li liRepresent TLE at both local site meetings and cross functional global meetings. /li liRepresent Qualification and Cleaning/Sterilization Validation aspects during inspections. /li liProvide direction, give guidance and implement procedures in agreement with TLE Lead. /li liResponsible for the area’s implementation of process changes, and root cause investigation of deviations. /li liResponsible for the evaluation of innovative equipment / technologies with respect to Qualification, CSV, Cleaning/Sterilization Validation, reviewing user requirements. /li liIdentify and harmonize practices across the site in relation to Qualification and Cleaning/Sterilization Validation – simplifying processing to ensure compliance, while decreasing implementation effort. /li /ul h3Qualifications /h3 ul liUniversity degree preferable in Engineering, Biotechnology, Biology, Microbiology. /li liMinimum 5 years of experience in pharmaceutical environment with minimum 2 years of experience in computer system validation, equipment qualification and cleaning validation. /li liExcellent know-how of current GMP regulations and industrial standards. /li liExtensive experience in Auditing and Compliance within pharmaceutical industry. /li liChange and Deviation Management experience. /li liStrong Project Management skills: organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines, and ensuring on-time delivery. Can define and lead projects to support improvement, implementation or remediation. /li liStrong communication skills: Plans and delivers ideas and information to others in a clear and impactful manner. /li /ul /p #J-18808-Ljbffr