Validation Engineer

We are currently supporting a major biopharmaceutical organisation in Germany and are looking for experienced Validation Engineers to join their project teams. This role will be key in ensuring compliance, quality, and successful delivery of projects as a new facility moves into its commissioning and qualification phase.

As a Validation engineer, you will independently lead and execute validation activities across equipment, utilities, facilities, computerised systems, and processes. You will act as a primary point of contact for clients, guiding projects from planning to completion while ensuring adherence to GxP standards and international regulatory requirements.

• Lead and manage qualification and validation activities across equipment, utilities, facilities, computerised systems, and processes
• Prepare, review, and approve key documentation (Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, Validation Reports)
• Troubleshoot validation issues, perform root cause analysis, and propose compliant, pragmatic solutions
• Support process, method, and cleaning validation activities in manufacturing, QC, and packaging environments
• Manage project timelines, resources, and deliverables to ensure successful execution
• Act as the client-facing lead, representing validation topics in meetings, workshops, and audits
• Identify opportunities to introduce digital tools and automation to improve validation efficiency

• Bachelor’s, Master’s degree or PhD in Life Sciences, Engineering, Computer Science, or related discipline
• 3+ years of hands-on experience in Qualification and Validation in the life sciences industry (pharma, biotech, medtech)
• Strong knowledge of regulatory requirements and guidelines: GxP, FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP 5
• Proven experience in risk-based validation approaches and leading validation activities from start to finish
• Fluent in English; German is a plus but not required