(Senior) Consultant Qualification & Validation

Project Services  - Frankfurt, Basel

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Your profile / requirements

• Bachelor’s, Master’s degree or PhD in Life Sciences, Engineering, Computer Science or a related field 
• Additional certifications (advantageous): e.g. GAMP5 Practitioner, Computer System Validation (CSV) certifications, Six Sigma Green Belt 
• 3–5 years of hands-on experience in Validation and Qualification within the Life Science industry (e.g. pharma, biotech, medtech) 
• Proven experience leading validation and qualification activities (equipment, utilities, facilities, computer systems, processes) 
• Demonstrated track record in managing client-facing projects, including client communication and relationship management 
• Experience in risk-based validation approaches and knowledge of current regulatory expectations (e.g. FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP 5) 
• Practical experience in authoring, reviewing and approving validation documentation (Validation Plans, URS, IQ/OQ/PQ protocols, Validation Reports) 
• Deep understanding of GxP, data integrity and regulatory requirements across global markets (FDA, EMA, WHO) 
• Advanced knowledge of validation project management methodologies (traditional and agile approaches) 
• Proficiency with validation lifecycle management tools (e.g. ValGenesis, Kneat Gx) 
• Strong analytical skills, including root cause analysis and risk assessment in validation contexts 
• Ability to implement digital validation solutions and drive process optimisation initiatives 
• Strong communication and presentation skills, including the ability to lead client meetings, workshops and audits 
• Excellent problem-solving skills, with the ability to propose innovative, compliant solutions 
• High adaptability to manage change and ambiguity in dynamic project environments 
• Strong time management skills with the ability to handle multiple validation projects in parallel 
• Ability to mentor junior colleagues and support their development 
• Strong self-reflection and continuous improvement mindset 
• Cultural awareness and the ability to work effectively in diverse, international teams 
• Very good command of English and German 

Tasks and responsibilities

• Independently lead validation and qualification activities for equipment, utilities, facilities, computerised systems and processes 
• Ensure high-quality, compliant deliverables according to GxP standards and regulatory requirements (e.g. FDA, EMA, WHO, ISPE GAMP 5) 
• Prepare, review and approve validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols and Validation Reports 
• Troubleshoot validation-related issues, identify root causes and propose pragmatic, compliant solutions 
• Prepare, execute and document processes validation for Manufacturing, Labelling and Packaging  
• Prepare, execute and document Method validation for Analytical Methods in QC and IPC 
• Prepare, execute and document cleaning validation for Production line and equipment like cleaning, mobile & multipurpose 
• Manage project timelines, resources and deliverables to ensure successful project execution 
• Act as the main client contact for validation-related topics, leading client meetings, workshops and project communications 
• Build and maintain strong client relationships, ensuring client satisfaction and identifying additional business opportunities 
• Mentor and support junior team members in validation best practices, documentation standards and regulatory expectations 
• Contribute to the continuous improvement of validation and qualification methodologies and internal processes 
• Participate in internal initiatives, such as knowledge management, tool evaluations and thought leadership (e.g. whitepapers, webinars) 
• Lead quality assurance activities within validation projects, ensuring adherence to internal and client-specific quality standards 
• Support change management activities related to validation projects, helping clients manage regulatory changes and new technologies 
• Identify areas where digital tools and automation could enhance validation efficiency and propose appropriate solutions 

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