Commissioning & Qualification Engineer
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:
- 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 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 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.
