CQV Engineer

vor 21 Stunden

Luzern, Schweiz Aristo Group Vollzeit

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MSP Lead | MSP Partnering at Aristo Group | Empowering Life Science with the Perfect Match

The Qualification, CSV and Cleaning/Sterilization Validation Engineer is a role within the Validation Unit team. This function supports 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.

Job title: CQV Engineer

Start of project: 02.02.2025

Duration of the project: 12 months

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, and 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.

Qualification:

  • 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.
Seniority level
  • Associate
Employment type
  • Contract
Job function

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