Qualification & Validation Engineer
vor 3 Wochen
This function supports Qualification and Cleaning/Sterilization Validation projects. It is in the responsibility of this function to implement new systems and processes to a state of permanent inspection readiness.
The person will ensure 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.
General Information:
Start date: ASAPDuration: 1 yearExtension: very likelyWorkplace: LucerneWorkload: 100%Home office: 1-2 days per week possible
The Primary Responsibilities include but are not limited to the following:
Executes site projects related to Qualification, CSV, Cleaning/Sterilization Validation:Support coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations.Support for the development / review / improvement of Qualification and CSV, Cleaning/Sterilization Validation Documentation: such as SOPs, qualification/validation documents, reports.Support for compliance deliverables and technical deliverables related to qualification and validation.Act as a point of contact deputy for Qualification and Cleaning/Sterilization Validation at the entire WAG Site.Support with Qualification and Cleaning/Sterilization Validation aspects during inspections.Support the implementation of procedures in agreement with VU Lead.Support the area's implementation of process changes, and root cause investigation of deviations.Support the evaluation of innovative equipment / technologies with respect to Qualification, CSV, Cleaning/Sterilization Validation, reviewing user requirements.Support to identify and harmonize practices across the site in relation to Qualification and Cleaning/Sterilization Validation – simplifying processing to ensure compliance, while decreasing implementation effort.
Your Profile:
University degree preferable in Engineering, Biotechnology, Biology, Microbiology.Minimum 5 years of experience in pharmaceutical environment with experience in computer system validation, equipment qualification and cleaning validation.Good know-how of current GMP regulations and industrial standards.Experience in Auditing and Compliance within pharmaceutical industry preferred.Change and Deviation Management experience.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.Strong communication skills: Plans and delivers ideas and information to others in a clear and impactful manner.Fluent English and basic German skills
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