(Senior) Consultant Qualification & Validation - Freelancer

Stellenbeschreibung:

As a (Senior) Consultant Qualification & Validation, you will play a key role in ensuring compliance and quality within the life sciences industry. You will independently manage and execute qualification and validation activities for equipment, utilities, facilities, computerised systems, and processes, ensuring adherence to GxP standards and global regulatory requirements (FDA, EMA, WHO, ISPE GAMP 5). Acting as a primary contact for clients, you will lead projects from planning to completion, provide strategic guidance, and build strong client relationships. This role requires working on-site at client locations across Germany, providing hands‑on support and ensuring successful project delivery.

Key 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 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
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

Qualifications, Skills and Experience

Education & Experience:

Bachelor’s, Master’s degree or PhD in Life Sciences, Engineering, Computer Science or a related field
Additional certifications (advantageous): e.g. GAMP5 Practitioner
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)
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)
Demonstrated track record in managing client‑facing projects, including client communication and relationship management
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
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