Bioinformático

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!

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