CSV Specialist / Senior CSV Engineer

# Senior CSV Engineer (m/f/d) – Shape the Future of a Growing CDMO Are you ready to be a key architect in a rapidly expanding international pharmaceutical environment? Following the strategic acquisition of our Homburg site, Famar is looking for a **Senior Computerized Systems Validation (CSV) Engineer**. In this role, you won't just follow protocols—you will help build the validation framework for a growing team, acting as the primary subject matter expert (SME) for Group Quality. If you thrive in a "builder" environment where you can shape processes rather than just maintaining them, this is your next career step. ## Your Core Responsibilities - **Lead Validation Lifecycle:** Plan and oversee IQ, OQ, and PQ for manufacturing equipment, lab instruments, and software applications (ERP/MES). - **Quality Governance:** Ensure full compliance with **EudraLex Vol. 4, 21 CFR Part 11, and Annex 11**. - **Risk Management:** Utilize tools like **FMEA and PHA** to drive risk-based validation approaches. - **Project Management:** Manage implementation projects as a lead, coordinating with IT, engineering, and external service providers. - **Audit & Support:** Act as a lead/co-auditor for internal and supplier audits; serve as the SME during regulatory inspections. - **Data Integrity:** Champion the Famar Data Integrity program across all functional business units. ## Your Profile - **Education:** Bachelor’s degree in Engineering, Chemistry, Computer Science, or a related field. - **Experience:** 5+ years in CSV within the **Pharma/MedTech** industry. Experience with PLC/HMI systems and automation is essential. - **Methodology:** Expert knowledge of **GAMP5** and the validation lifecycle. - **Technical Skills:** Proficient in MS Project and Visio. - **Languages:English:** Excellent (C1/C2) for international collaboration.**German:** B1 in speaking and writing - **Soft Skills:** Strong analytical mindset, "multi-tasking" capability, and the ability to build constructive relationships across different cultures. ## Why Famar Healthcare? - **Growth & Impact:** They are currently in a high-growth phase. You will have the unique opportunity to help design the department's future structure. - **International Reach:** Work within a global network with potential opportunities for international projects. - **Competitive Benefits:** 30 days of vacation, company pension scheme with employer contribution, and "Jobbike" leasing. - **Culture:** A supportive, professional team environment with flat hierarchies. We are looking to fill this position **immediately**. If you have a background in high-level consultancy or extensive experience in a CDMO environment, we especially want to hear from you. **Apply now and help us set new standards in pharmaceutical quality!**