CQV Manager
vor 3 Wochen
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life‑saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same. YOUR ROLE We’re seeking an experienced C&Q Manager to take on a strategic leadership role in a fast‑paced, high‑visibility project. This position requires strong project and people management skills, with a focus on navigating complex scopes and overcoming planning challenges. Success in this role is driven by adaptability, resilience, and the ability to lead teams through uncertainty with confidence and clarity. Key Responsibilities: Lead and manage commissioning and qualification activities across multiple sites. Ensure compliance with GMP, FDA, EMA, and other regulatory standards. Oversee the full validation lifecycle: DQ, IQ, OQ, PQ. Apply risk‑based qualification approaches (e.g., ASTM E2500). Manage documentation including URS, FAT/SAT, protocols, and final reports. Coordinate with cross‑functional teams, vendors, and regulatory bodies. Use project management tools (e.g., MS Project, Primavera) for planning and execution. Mentor junior staff and manage external consultants. YOUR SKILLS AND EXPERIENCE KNEAT Experience: Highly valued and prioritized. GMP & Regulatory Knowledge: Strong understanding of compliance frameworks. Validation Lifecycle Expertise: DQ, IQ, OQ, PQ. Risk-Based Qualification: ASTM E2500 familiarity. Process & Equipment Knowledge: Cleanroom classifications, HVAC, utilities (WFI, compressed air), automation systems. Documentation & Protocols: Skilled in writing and reviewing qualification documents. Project Management Tools: MS Project, Primavera, or similar. Resilience: Proven ability to lead projects through adversity to success. Communication: Clear and effective across diverse teams and stakeholders. Leadership & Team Management: Experience managing multidisciplinary and offshore teams. German language skills are highly desirable. WHAT YOU’LL LOVE ABOUT WORKING HERE? At our engineering academy, you’ll have access to over 60,000 hours of world‑class training – designed to fuel your growth from day one. Whether you're diving into Generative AI, data science, or sustainability, our digital campus supports your learning journey every step of the way. Experience the benefits of hybrid working, offering flexibility and ensuring work‑life balance. Harness the strength of diverse teams, fostering innovation and inclusive collaboration. We offer additional benefits such as 5 weeks of vacation, Employee referral bonus, Company shares program and annual contribution to a fitness subscription. Capgemini Switzerland is an equal opportunity employer. We promote equality and dignity in all aspects of recruitment and employment, and all offers of employment and promotions are made on the basis of performance, competence and ability. #J-18808-Ljbffr
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CQV Manager: GMP/Regulatory Validation Lead
vor 2 Wochen
Zürich, Schweiz Capgemini VollzeitA global leader in engineering services is seeking an experienced C&Q Manager in Zurich, Switzerland. This role involves leading commissioning and qualification activities across multiple sites while ensuring compliance with regulatory standards. Candidates should have expertise in validation lifecycle and project management tools, and be able to effectively...