Headcount is sourcing a Validation Engineer for a leading client’s biotech. This is an urgent requirement and the person will be required to collaborate and facilitate running of activities such as PPQ batch manufacture, validation activities, investigations, and change control.
Ensure the highest Quality, Compliance and Safety standards primarily not only with Technical/Validation activities but relating to all activities to enable the team’s performance in the Vaccine Technical Group within the vaccine value stream.
Project validation support including conducting equipment performance qualifications (cleaning and sterilization validation periodic reviews, re-qualifications, temperature mapping).
Authoring project validation master plans, SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data.
Resolving technical issues encountered during study execution. Lead and close process related deviations and reports and participate in problem solving teams across all areas of the vaccine value stream (e.g. reliability, Safety, Quality (e.g. CAPA/DN/MDNs etc).
This individual will be required to work in a cross-functional team and independently to accomplish validation project objectives.
Technical review, ownership of and approval of Global Change Management records as required.
Recommend technical approaches in line with global and local standards.
Contribute for driving a culture of Continuous Improvement by deploying Company Six Sigma tools and MPS within the Integrated Project Team on projects such as: problem solving, reducing cycle time, lean principles within the new processes.
Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
Preference for Lean Six Sigma qualification or experience of application of Lean principles
Project management qualification such as, Project Management Professional is desirable
Evidence of Continuous Professional Development is advantageous.