Commissioning & Qualification Engineer - II
QLS are recruiting for a Commissioning and Engineer II to join a Global Biopharmaceutical company based in Lucerne on a 12 months contract.
The Qualification and Cleaning/Sterilization Validation Subject Matter Expert (SME) is a role within theValidation Unit team. This function leads/supervises 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.Main responsibilities include:
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 and Cleaning/Sterilization Validation at the entire WAG Site. o Represent Validation Unit atboth local site meetings and cross functional global meetings. o Represent Qualification 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 and Cleaning/Sterilization Validation – simplifying processing to ensure compliance, while decreasing implementation effort.
Your qualification:
- 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 communicationskills: Plans and delivers ideas and information to others in a clear and impactful manner.
Apply:
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could yousend any correspondence in English. Please quote job reference 56280 in all correspondence.
