Company Overview
Project Services
(Senior) Consultant Qualification & Validation
-Independently lead Validation and Qualification activities for Production / QC equipment, utilities like WFI, N2 and facilities like cleanroom, warehouse etc.
-Ensure high-quality, compliant deliverables according to GxP standards and regulatory requirements (e.g. FDA, EMA, WHO, ISPE GAMP 5) and clients’ quality standards
-Prepare, review and approve Commissioning / Qualification / Validation documentation, including Q&V Plans, URS, Risk Assessments, IQ/OQ/PQ protocols and Validation Reports
-Execute tests and document according to GdP and clients’ requirements
-Troubleshoot Q&V-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, mobile & multipurpose
-Manage project timelines, resources and deliverables to ensure successful project execution and project communications
-Act as the main client contact for Q&V-related topics, leading workshops with client and vendors
-Support change management activities related to Q&V projects, helping clients manage regulatory changes and new technologies
-Build and maintain strong client relationships, ensuring client satisfaction and identifying additional business opportunities
-Mentor and support junior team members in Q&V best practices, documentation standards and regulatory expectations
-Contribute to the continuous improvement of Q&V methodologies and services
-Identify areas where digital tools and automation could enhance Q&V efficiency and propose appropriate solutions
-Participate in internal initiatives, such as knowledge management, tool evaluations and thought leadership (e.g. whitepapers, webinars)
1
-Bachelor’s, Master’s degree or PhD in Life Sciences, Engineering, Computer Science or a related field
-3–5 years of hands-on experience in Qualification & Validation within the Life Science industry (e.g. pharma, biotech, medtech)
-Proven experience leading Qualification & Validation activities (equipment, utilities, facilities, processes)
-Demonstrated track record in managing client-facing projects, including client communication and relationship management
-Experience in risk-based Q&V approaches and knowledge of current regulatory requirements (e.g. FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP 5)
-Practical experience in authoring, reviewing and approving Q&V documentation (Q&V Plans, URS, IQ/OQ/PQ protocols, Q&V reports)
-Deep understanding of GxP, data integrity and regulatory requirements across global markets (FDA, EMA, WHO)
-Advanced knowledge of Q&V project leadership & project management
-Strong time management skills with the ability to handle multiple Q&V projects in parallel
-Proficiency with Q&V lifecycle management tools (e.g. ValGenesis, Kneat Gx)
-Strong analytical skills, including root cause analysis and risk assessment in Q&V- contexts
-Ability to implement digital Q&V solutions and drive process optimisation initiatives
-Additional experience in Computer System Validation (CSV) is a plus
-High flexibility and mobility to work onsite at the client
-Very good command of German and English (German is a MUST)
-Strong communication and presentation skills, including the ability to lead client meetings, workshops and participate in 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 self-reflection and continuous improvement mindset
-Cultural awareness and the ability to work effectively in diverse, international teams
2284
Frankfurt
Company Overview
Project Services
-Independently lead Validation and Qualification activities for Production / QC equipment, utilities like WFI, N2 and facilities like cleanroom, warehouse etc.
-Ensure high-quality, compliant deliverables according to GxP standards and regulatory requirements (e.g. FDA, EMA, WHO, ISPE GAMP 5) and clients’ quality standards
-Prepare, review and approve Commissioning / Qualification / Validation documentation, including Q&V Plans, URS, Risk Assessments, IQ/OQ/PQ protocols and Validation Reports
-Execute tests and document according to GdP and clients’ requirements
-Troubleshoot Q&V-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, mobile & multipurpose
-Manage project timelines, resources and deliverables to ensure successful project execution and project communications
-Act as the main client contact for Q&V-related topics, leading workshops with client and vendors
-Support change management activities related to Q&V projects, helping clients manage regulatory changes and new technologies
-Build and maintain strong client relationships, ensuring client satisfaction and identifying additional business opportunities
-Mentor and support junior team members in Q&V best practices, documentation standards and regulatory expectations
-Contribute to the continuous improvement of Q&V methodologies and services
-Identify areas where digital tools and automation could enhance Q&V efficiency and propose appropriate solutions
-Participate in internal initiatives, such as knowledge management, tool evaluations and thought leadership (e.g. whitepapers, webinars)
1
-Bachelor’s, Master’s degree or PhD in Life Sciences, Engineering, Computer Science or a related field
-3–5 years of hands-on experience in Qualification & Validation within the Life Science industry (e.g. pharma, biotech, medtech)
-Proven experience leading Qualification & Validation activities (equipment, utilities, facilities, processes)
-Demonstrated track record in managing client-facing projects, including client communication and relationship management
-Experience in risk-based Q&V approaches and knowledge of current regulatory requirements (e.g. FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP 5)
-Practical experience in authoring, reviewing and approving Q&V documentation (Q&V Plans, URS, IQ/OQ/PQ protocols, Q&V reports)
-Deep understanding of GxP, data integrity and regulatory requirements across global markets (FDA, EMA, WHO)
-Advanced knowledge of Q&V project leadership & project management
-Strong time management skills with the ability to handle multiple Q&V projects in parallel
-Proficiency with Q&V lifecycle management tools (e.g. ValGenesis, Kneat Gx)
-Strong analytical skills, including root cause analysis and risk assessment in Q&V- contexts
-Ability to implement digital Q&V solutions and drive process optimisation initiatives
-Additional experience in Computer System Validation (CSV) is a plus
-High flexibility and mobility to work onsite at the client
-Very good command of German and English (German is a MUST)
-Strong communication and presentation skills, including the ability to lead client meetings, workshops and participate in 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 self-reflection and continuous improvement mindset
-Cultural awareness and the ability to work effectively in diverse, international teams
2284
Frankfurt