Commissioning & Qualification Engineer - III.

For one of our clients, an international company in Luzern, we are looking for a 
Commissioning & Qualification Engineer - III
 

• Start date: 03.07.2023
• End date: 30.06.2024
• Workplace: Luzern
• Workload: 100%

The Qualification, Computer System Validation (CSV) and Cleaning/Sterilization Validation Subject Matter Expert (SME) is a role within the Validation Unit team. This function leads/supervises qualification, CSV 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.


Responsibilities:

The Primary Responsibilities include but are not limited to the following:
• Lead/Supervision of site projects related to Qualification, CSV, Cleaning/Sterilization Validation:
o Lead coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations.
o Responsible for the development / review / improvement of Qualification and CSV, Cleaning/Sterilization Validation Documentation: such as SOPs, qualification/validation documents, reports.
o Responsible for compliance deliverables and technical deliverables related to qualification and validation.
• Act as an SME and point of contact for Qualification, CSV and Cleaning/Sterilization Validation at the entire WAG Site.
o Represent Validation Unit at both local site meetings and cross functional global meetings.
o Represent Qualification, CSV and Cleaning/Sterilization Validation aspects during inspections.
o Provide direction, give guidance and implement procedures in agreement with VU Lead.
• Responsible for the area’s 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, CSV and Cleaning/Sterilization Validation – simplifying processing to ensure compliance, while decreasing implementation effort.


Qualifications:

• University degree preferable in Engineering, Biology, Microbiology.
• Minimum 5 years of experience in pharmaceutical environment with minimum 3 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