QA Specialist - CSV & Automation (m/f/d) Freelance/temporary employment for a project Stein Start date: asap Reference number: 853873/1 Responsibilities * Ensure qualification and validation plans for equipment, infrastructure, and computerized systems comply with Lonza Quality policies * Review and approve SOPs, commissioning/qualification/validation protocols, reports, and CQV/CSV documentation (e.g., URS, FAT/SAT) * Provide QA leadership and guidance on qualification/validation topics for large-scale CAPEX projects * Act as primary QA contact for lifecycle compliance of equipment and computerized systems, including documentation in global systems (Kneat, Trackwise, DMS, Unifier) * Oversee vendor qualification and ensure adherence to GMP standards * Manage quality deviations, changes, and CAPAs, ensuring timely resolution and escalation when necessary * Support project teams during design, commissioning, and qualification phases for aseptic fill-finish facilities * Collaborate cross-functionally to maintain compliance throughout project execution * Contribute to continuous improvement initiatives in QA processes and systems * Ensure compliance with regulatory requirements and internal quality standards Profile * Bachelor-s or Master-s degree in Engineering, Life Sciences, or a related field * Significant experience in GMP-regulated pharmaceutical environments, preferably within a Quality Unit * Proven expertise in QA for CSV and automation of GMP systems, especially aseptic fill-finish processes * Strong knowledge of equipment and utilities such as filling lines, lyophilization, clean utilities, and cleanroom facilities * Familiarity with global QA systems (e.g., Kneat, Trackwise, DMS, Unifier) * Ability to interpret and approve technical documentation (URS, FAT/SAT, protocols) * Excellent problem-solving and decision-making skills in a regulated environment * Fluent in English; German language skills are an advantage * Strong communication and stakeholder management abilities * Ability to work independently and lead QA activities for complex projects Benefits * Opportunity to work on high-impact CAPEX projects in a global pharmaceutical leader * Collaborative and innovative work environment with cross-functional teams * Exposure to cutting-edge technologies and GMP compliance practices * Inclusive and diverse workplace culture