The
CQV Engineer
is a role within the Validation Unit team. 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 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 asap
Duration of the project 12 months
Primary Responsibilities
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.
Qualifications
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.
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CQV Engineer
is a role within the Validation Unit team. 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 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 asap
Duration of the project 12 months
Primary Responsibilities
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.
Qualifications
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.
#J-18808-Ljbffr
CQV Engineer m/w/d Arbeitgeber: Aristo Group
Aristo ist ein hervorragender Arbeitgeber, der dir als Senior Recruitment Consultant (w/m/d) nicht nur ein überdurchschnittliches Gehalt und ein transparentes Karrieremodell bietet, sondern auch die Möglichkeit, in einem dynamischen Team zu arbeiten, das sich auf den Aufbau der Life Science Sparte konzentriert. Mit flexiblen Arbeitsmodellen, regelmäßigen Teamevents und einem starken Fokus auf persönliche Weiterentwicklung schaffst du nicht nur einen bedeutenden Beitrag zum Unternehmen, sondern profitierst auch von einer positiven und unterstützenden Unternehmenskultur in einer der schönsten europäischen Metropolen.
