Commissioning & Qualification Engineer
Job Location:
Job Location:
Lucerne - Switzerland
Salary:
Not Disclosed
Salary:
Posted on:
16 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
The 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.
The Primary Responsibilities include but are not limited to the following:
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.
The Primary Responsibilities include but are not limited to the following:
- Lead/Supervision of site projects related to Qualification CSV Cleaning/Sterilization Validation:
- Lead coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations.
- Responsible for the development / review / improvement of Qualification and CSV Cleaning/Sterilization Validation Documentation: such as SOPs qualification/validation documents reports.
- Responsible for compliance deliverables and technical deliverables related to qualification and validation.
- Act as an SME and point of contact for Qualification and Cleaning/Sterilization Validation at the entire Site.
- Represent TLE at both local site meetings and cross functional global meetings.
- Represent Qualification and Cleaning/Sterilization Validation aspects during inspections.
- Provide direction give guidance and implement procedures in agreement with TLE Lead.
- Responsible for the areas implementation of process changes and root cause investigation of deviations.
- Responsible for the evaluation of innovative equipment / technologies with respect to Qualification CSV Cleaning/Sterilization Validation reviewing user requirements.
- Identify and harmonize practices across the site in relation to Qualification and Cleaning/Sterilization Validation simplifying processing to ensure compliance while decreasing implementation effort.
- University degree preferable in Engineering Biotechnology Biology Microbiology.
- Minimum 5 years of experience in pharmaceutical environment with minimum 2 years of experience in computer system validation equipment qualification and cleaning validation.
- Excellent know-how of current GMP regulations and industrial standards.
- Extensive experience in Auditing and Compliance within pharmaceutical industry.
- Change and Deviation Management experience.
- Strong 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.
About Company
Idibu
100 employees
Every business is now operating in an environment that’s susceptible to change. idibu has evolved against this changing backdrop. Whether driven by legislation, technology, customer demand or the economy, businesses now need to be agile and fleet of foot to ensure they can attr ... View more
