bioinformaticien/ne

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!

Nos offres d'emploi s'adressent toujours à toutes les personnes capables de travailler, quels que soient leur âge, leur sexe, leur origine, leur orientation sexuelle, leur handicap, leur religion et leur idéologie, etc. Les candidats sont exclusivement sélectionnés sur la base de leurs qualifications. Les erreurs dans les informations données et l'orthographe sont réservées.