Company Overview
Project Services
(Senior) Consultant Qualification & Validation
- 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
1
- 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
2284
Frankfurt
Company Overview
Project Services
- 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
1
- 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
2284
Frankfurt