* Engineering - Quality Management * Aargau * Contracting * Vollzeit * January 2025 - December 2026 * Quality Assurance, CSV Contract duration: 1 year Location: Stein Responsibilities * Oversee and ensure qualification and validation compliance for equipment, infrastructure, and computerized systems associated with aseptic drug product manufacturing and related utilities. * Provide QA support for major CAPEX projects (e.g., new drug product facilities), ensuring quality requirements are embedded from concept through design and execution phases. * Ensure that qualification/validation strategies, plans, and execution activities comply with quality policies and applicable regulations. * Review and approve commissioning, qualification, and validation documentation, including SOPs, URS, FAT/SAT protocols, validation protocols, and final reports. * Offer QA leadership and expert guidance to project teams on qualification, validation, and CSV topics across ongoing CAPEX initiatives. * Ensure appropriate qualification of vendors and assessment of supplier-provided documentation. * Serve as the primary Quality point of contact within GQE for all matters relating to equipment, infrastructure, and computerized-system lifecycle management and compliance. * Ensure proper documentation and traceability within global quality systems (e.g., Kneat, TrackWise, DMS, Unifier). * Manage Quality deviations, change controls, and CAPAs/tasks, ensuring timely resolution and escalation where appropriate. Requirements * Bachelor-s or Master-s degree in Engineering, Life Sciences, or a related scientific/technical discipline. * Significant experience working within a GMP-regulated pharmaceutical environment, ideally within a Quality Unit. * Demonstrated experience in a QA role focused on CSV and automation for GMP systems, particularly those supporting aseptic fill-finish operations (e.g., filling equipment, lyophilizers, clean utilities, cleanroom facilities). * Strong understanding of qualification/validation requirements for equipment and computerized systems within a pharmaceutical manufacturing setting. * Ability to influence project teams and provide clear, authoritative QA direction in a dynamic environment. * Excellent communication skills in English; German language skills are an advantage.